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quality & compliance

Compliance solutions for product development agility & audit readiness

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An industry leader in quality & compliance 

The path for medical devices and diagnostics development is different from drug development, and at ProPharma we have a dedicated team of experts who focus solely on supporting our device and diagnostics clients. Our experts understand what it takes to get these products to market. Regardless of whether you are just starting through the development process with your first product or are an established device or diagnostics company, we can tailor the solution that gets you to market quickly and efficiently.

Quality & Compliance Services

An expansive suite of services to ensure quality, compliance, efficiency, and safety throughout the full lifecycle of a product. Our Quality & Compliance experts support you with the highest quality of services by providing best practices and proven insights on program and process management.

 

Consulting Services

ProPharma's Quality and Compliance Team offers consulting services to help clients make informed decisions about the challenges they face. We will connect you with an expert in the healthcare industry to answer your questions on a variety of topics. Our team of experts has completed thousands of projects in almost every facet of healthcare and can provide compliant, effective solutions in an efficient way.

Computer System Validation

ProPharma's validation professionals leverage the latest risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques to ensure that our clients' systems are ready for inspections from the FDA, EMA, MHRA, and other regulatory agencies. Our consultants have extensive experience in the pharmaceutical, biotech, medical device, clinical research, and software industries.

  • Cloud-based (SaaS and PaaS) applications
  • Configured Off-the-Shelf (COTS) applications
  • On prem and cloud-based (IaaS) infrastructure
  • Initial validation, retrospective validation, and ongoing validation for software updates

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Part 11 and Annex 11 Compliance

Compliance with FDA 21 CFR 11 Electronic Records; Electronic Signatures and EU Annex II Computerised Systems is a must in our industry. If your organization's growth depends on compliance with Part 11 or Annex 11, ProPharma has the experts you need to get your systems, procedures, validation documents, and employees ready.

Data Integrity

Data without integrity puts patients at risk. Data Integrity is a “hot topic” because many of the controls implemented decades ago for paper records, have not yet been implemented for electronic records and computer systems in spite of recent guidelines from the FDA, EMA, MHRA, PIC/S, and WHO. Our experts have experience applying the ALCOA principles to real-life scenarios to minimize data integrity risks through remediation of systems, policies, procedures, and data governance programs.


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Compliance

ProPharma specializes in solving complex challenges. Our experienced compliance consulting professionals will seamlessly integrate with your team to do more than simply identify potential risks. We provide recommendations to mitigate those risks and will work side-by-side with you to implement improvement plans and collaborate with your team in addressing those risks.

From early concept development through each clinical phase, product launch, and commercialization, our Quality and Compliance Consultants partner with clients around the world to help ensure regulatory expectations are met, business goals are achieved, and patient health and safety is assured and improved. We do this with an unwavering focus on delivering the highest quality services through our diverse team of qualified subject matter experts (SMEs). Having working experiences from large international corporations to small research companies as well as authorities such as FDA, EMA, MHRA, and national competent authorities, our experts drive operational excellence, and provide a sincere commitment to providing high-quality services. Our ability to be nimble coupled with a passion for excellence ensures our consulting services exceed clients’ expectations.

ProPharma performs quality and compliance consulting activities in all GxP areas. Our consultants have extensive management and operational experience in at least one GxP area (GMP, GDP, GVP, GCP, GLP, GCLP, and/or IT/CSV) and often in multiple areas of expertise.

Inspection Readiness and GxP Audits

Any firm that outsources regulated activities such as clinical studies, manufacturing of pharmaceutical products or medical devices, production of raw materials, or laboratory services requires routine qualification audits.

Companies are expected to be compliant and continuously improving. As your partner, we maintain alignment with new, existing, and changing regulations and industry standards that evolve throughout the drug product and device lifecycle. Our GxP auditors have real world experience supporting regulatory inspections and preparing companies for pre-approval inspections (PAI).

Professional GxP auditors reviewing data on computer screen

Our team of specialists includes former regulatory agency inspectors and qualified auditors who are proficient in conducting mock inspections, internal audits, vendor and supplier auditing, and gap assessments. We serve as an extension of our client’s Quality Department with respect to vendor and supplier auditing or act as a mock regulatory agency representative with respect to preparing your organization for an agency inspection. Partnering in a constructive and collaborative manner, we work together to understand, identify, and evaluate systems for quality improvements.

With offices and quality and compliance consultants located all over the world, ProPharma offers the availability to execute audits in different GxP areas on a global basis with diverse language skills, creating efficiencies in both time and money. Our large team of qualified auditors have a breadth of expertise across the entire development and regulatory spectrum (GMP, GCP, GLP, GCLP, GPV, ISO-13485, CSV, Data Integrity, etc.).

Explore GxP Audits, Consulting, and Inspections

Quality Investigations and CAPA Support

A key component of any modern quality system is the risk-based response to observed manufacturing, testing, and distribution discrepancies, or as the result of product complaints. Good Manufacturing Practice (GMP) regulations and industry guidance all describe the criticality of implementing a structured approach to performing investigations with the intent of determining root cause of the discrepant issue. Determining the root cause is necessary to implement specific and effective corrective and preventative action (CAPA) to remediate and prevent reoccurrence of the issue, and consequently facilitate continuous improvement.

For over 20 years our experts have delivered thousands of investigation reports with teams ranging in size from a single investigator up to teams of 45+. Our project success follows a thorough project initiation procedure that dictates everything from onboarding to resource loading through execution of deliverables and metrics reporting. Our diverse and experienced SMEs are another key to our success. The lifecycle of discrepancy and complaint management can be quite complex and often requires input from multiple subject experts. ProPharma has all the experts needed to support your program. Our team will integrate with yours and provide investigation and CAPA support within your quality system, or we will help to develop and optimize your program. Our team has a wealth of knowledge accumulated through many years of industry support in consulting roles as well as operating company management defending investigation and CAPA systems to regulatory bodies.

When you partner with ProPharma, you gain the experience of the entire company—not just the team assigned to your project. This breadth and depth of knowledge enables ProPharma to provide you with the support and guidance you need when you need it.

EU and UK Batch Release through the ProPharma MIA License

Navigating both the specific country and general European regulations and requirements to supply medicinal products to the European markets can be a complex challenge. This applies both to Marketing Authorisation Holders (MAH) of approved medicinal products and sponsors of clinical trials.

On top of the varying requirements, MAH/Sponsors looking to enter the European markets must create tailored supply strategies per country and establish a legal entity with a Manufacturing and Importation Authorisation (MIA) and a named Qualified Person (QP) in the region.

All of which can be extremely difficult for even the most experienced individuals. The QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing or clinical trial authorisation (MA/CTA) and with GMP.

Partnering with the leading industry compliance experts will help unravel these complexities to improve business efficiency, shorten timelines, and reduce overall costs. This will allow you to further focus on product development, clinical studies, and commercialization to support patient access and safety.

ProPharma hold both EU and UK MIAs which allows us to help clients overcome the complexities of accessing the EU and UK markets, like navigating country and EU regulations and creating tailored strategies per country. It also negates the need for MAH/Sponsors to obtain its own MIA license with a QP in the region. All of which helps ensure products are released to patients in need across the EU and UK in a quick and flexible way. Especially if speed to market is an issue since obtaining an own MIA license is a much longer process (>1 year) compared to listing your medicinal products on ProPharma's license (3-4 months).

ProPharma can perform QP Batch Certification services under its own MIA licenses for pharmaceutical and biotech clients launching products to the European and UK markets, as well as release for export from the EU (e.g., to the United States). This applies to both new and existing products. Listing your products on the ProPharma MIA licenses gives you access to skilled and experienced QP's for multiple types of products/formulations including biologics, ATMPs, vaccines and small molecules.

Learn more about ProPharma's MIA License

Qualified Person (QP), Responsible Person/Responsible Person Import (RP/RPi)

Every organization in the life sciences industry is required to have a current and compliant quality system to ensure the safety and quality of all products and services. Quality assurance entails the maintenance of a desired level of quality in your products during every stage of the process, from production to delivery.

At ProPharma, our quality assurance professionals augment your internal capabilities to ensure products are consistent and safe. Our team acts as an extension of your Quality Unit, utilizing a hands-on and risk-based approach to quickly improve quality and compliance, and implement practical solutions for your organization.

Companies that intend to manufacture or import medicinal products in the EU and UK require an MIA license and a designated named Qualified Person to oversee the product quality throughout the supply chain. Acting as an extension of your organization, our QP consultants bring a deep understanding of GMP processes. They work with your team to ensure compliant manufacturing and/or importation of products in the EU and UK markets. Our global team of certified QPs have broad experience covering multiple types of formulations, complex supply chains, technical transfer projects, aseptic/sterile manufacturing, radiopharmaceuticals, biologics, ATMPs and supply for clinical trials.

To procure, sell and distribute medicinal products in the EU/UK markets you need a Wholesaler Dealer Authorization (WDA) and a Responsible Person (RP) named on the license. A WDA in the UK can also be used to import QP-certified medicinal products from the EU. In that case you would need a Responsible Person (import). The RP has the quality oversight of the company's wholesale operation and has the main responsibility to assure compliance with GDP regulations and that the quality of the products distributed is maintained.

Our highly experienced RPs can act as contractors named on your, or a third party's, WDA for both human and veterinary medicines under EU and UK Guidelines. If you are new to the EU/UK market we can help you navigate the road from QMS build, through the WDA application process, a successful inspection and obtaining your very own WDA license.


Explore Qualified Person (QP) Services

Remediation

Whether you have small- or large-scale operations in pharmaceuticals, biotechnology, medical device, or compounding pharmacies, we offer risk-based remediation services that can benefit your organization.

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ProPharma has a unique team of remediation professionals that organize and communicate the requirements of the remediation effort. This remediation team enables us to identify and track every action item required for compliance remediation and escalate potential concerns to project teams and/or executive management for resolution. We partner with you to build your remediation plan, perform gap assessments for all systems, and implement remediation efforts to ensure you are on schedule and within budget.

Regardless of your challenge, our team understands the complexities associated with compliance constraints and can support your organization to manage the remediation process to return your organization to an efficient and compliant operation.

Quality Management Systems (QMS) Development and Optimization

For pharmaceutical, biotech, and medical device manufacturers, Quality Management Systems (QMS) are the foundation for enabling the organization to operate in a compliant manner. The QMS establishes the path to compliance for the company and enables sustainable systems that meet the demands of regulators, customers, and ever-changing business environments.

We are a trusted partner in designing, building, and managing QMS programs. Our industry-leading experts understand the complex regulatory elements and the compliance systems that are required for your organization to succeed. We can help guide your team through the regulatory processes specific to your quality programs.

Our professionals ensure QMS achieves three objectives:

  • Continuous improvement
  • Regulatory requirements
  • Establish “right-sized” processes for the phase and scope of the organization


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Program & Project Management

We understand that you are constantly faced with complex projects with tight timelines, finding or freeing up resources to meet those deadlines, and are often dealing with trying to balance your daily work with yet another urgent initiative or critical pipeline project.

ProPharma’s Project Management offering provides the right resource or solution for the right project at the right time. Our project managers have seamlessly joined teams and successfully implemented projects, pipeline programs, and other transformational initiatives within pharmaceutical, biotech, and medical devices and diagnostics companies. Our practitioners share a winning approach that blends insights from their subject matter expertise, prior project successes/lessons learned, peer learnings, and fit-to-purpose project design.

Project Area Expertise

  • Clinical Development
  • Early and Late-Stage Drug Development
  • Global Medical Affairs
  • Manufacturing
  • Pharmacovigilance
  • Pre-Approval Inspections (PAI) Readiness
  • Product Development – Pharmaceutical, Biotechnology, Medical Device and Diagnostics
  • Quality Assurance – R&D and Manufacturing
  • Technology Transfer

We Specialize in These Types of Challenges

  • Identifying and staffing a skilled project manager to support your project needs
  • Assessing and optimizing your Project Management Office – PMO
  • Providing Project Management Outsourcing support for your function or department
  • Providing program management support for early- or late-stage drug development programs
  • Providing project management support for pre-approval inspection readiness and regulatory filings
  • Overseeing remediation efforts for device, diagnostic, or drug inspections and audits
  • Driving regulatory readiness for new regional/local device, diagnostic, or drug regulations
  • Driving project management activities for post-merger integrations

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R&D Process Optimization & Organizational Change Management (OCM)

We understand that throughout the R&D lifecycle, you are faced with multiple challenges such as addressing a process that is not efficient, looking for productivity opportunities, or developing a brand new process. ProPharma’s process optimization approach is collaborative in that we work with you to understand and address your process challenges while using a methodology rooted in lean six sigma and other industry leading process optimization techniques. Our experts will help you optimize your processes at any point in the R&D and Commercialization lifecycle.

To ensure that the updated or new process or project is successful, we integrate OCM processes based on PROSCI methodology to ensure that change impacts have been identified, assessed, and included in the solution, the appropriate stakeholders are aligned, communications and training have been developed/rolled out, and the organization has been sufficiently trained on the change(s). These steps will help to ensure these changes are sustained, post-completion of the project activities.

Post-Merger Integration

We understand that when your organization makes a significant investment in acquiring a new organization, excellence of post-merger integration execution is critical. But, for a Quality Assurance (QA) organization, there is an added complexity as both legacy organizations must execute ongoing activities and remain in compliance. It is not sustainable nor is it advisable to have two actively ongoing quality systems, long-term. This places the acquiring company with the difficult task of maintaining compliance across both systems and addressing potentially unnecessary cost, process, technology, and organizational redundancies.

ProPharma is deeply skilled in not only Post-Merger Integration, but also Quality Assurance processes and technology. The latter is an uncommon Project Management Institute (PMI) skill set and is extremely important in being able to effectively drive your QA groups to the desired future state. Our methodology and expertise in executing these activities can complement or drive your integration activities so you can realize integration success.

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Technology Transfer

We understand that as transfers of products and processes from one site to another are becoming more common, transfers can be complicated, lack detailed technology transfer plans, lack quality documentation, and/or lack internal expertise or have the bandwidth to efficiently complete the transfer.

We can effectively work with you using our proprietary and customizable Gated Technology Transfer methodology to meet your specific production and technology demands: development to production or from site to site in a compliant and efficient manner. We have successfully completed more than 175 product transfers using our Gated Technology Transfer approach. Clients credit this impactful methodology in helping them navigate the complexities of the technology transfer process while realizing efficiencies along the way.

Vendor Selection & Management Services

We understand that identifying and managing vendors can be overwhelming due to the sheer volume of options and the need to follow a structured and data driven path to make a decision.

Our identification services will save you time and effort by allowing us to interview you to understand your vendor needs, identify key selection criteria, and use our methodologies to identify potential partners. We have deep expertise in working with R&D and Manufacturing clients to manage the RFP process through the selection and confirmation processes to confirm the partner.

For management, we can work with you to develop and roll-out ongoing proactive governance and audit processes to ensure that your vendor’s objectives and activities are being completed as agreed upon contractually and there is a mechanism for issue and risk identification, escalation, and management.

 

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Commissioning, Qualification and Validation

At ProPharma, our life science consulting experts provide process validation services for the design, qualification, and continued verification of manufacturing processes that help clients maintain quality and compliance for cGMP regulated products.

Our global teams partner with you to ensure that each step of the validation process is properly mapped and executed. By working with our process validation experts, you can deliver the documented evidence needed to guarantee to regulatory agencies that careful and systemic attention is applied and that your product meets the necessary quality attributes.

ProPharma’s product lifecycle approach towards process validation in pharmaceuticals and biotech helps you deliver optimal product quality by identifying the presence and degree of process variation and the impact variation has on the process efficiency and product quality. Minimizing the variation reduces risks and ensures a robust process that reliably produces quality product.

Defining the commercial manufacturing process based on knowledge gained during development and scale-up activities.

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Process Design

Defining the commercial manufacturing process based on knowledge gained during development and scale-up activities.

  • Initial process design experiments do not necessarily need to conform to cGMP. This step should be based on the guidance of sound scientific foundations.
  • It is essential to follow good documentation practices. The studies that show an improvement of process understanding should be documented.
  • Repeated testing at this phase, until the process fails, is not generally expected according to the guidelines of the FDA.
  • The creation of process controls are required to ensure product quality, and also cover any variability in product. The FDA requires process controls to cover the examination of materials and equipment monitoring. Process control and monitoring is essential under the following circumstances:
    • The product attribute is not easily detected or measured
    • When products/intermediates are not well characterized.

Process Qualification

Performing the necessary evaluations to determine if a process is capable of reproducible commercial manufacturing.

  • Proper design of manufacturing facilities is necessary under cGMP requirements
  • Choosing appropriate utility systems and equipment. Equipment and utilities should be chosen according to documented design specifications.
  • Verify that systems and equipment will perform within the necessary specifications
  • Process Performance Qualification (PPQ) should be conducted holistically with the qualified utilities, facilities, equipment, and trained personnel associated with the manufacturing process. When possible, the FDA prescribes that objective measures such as statistical metrics should be utilized.
  • Written protocols and expected outcomes are crucial to process validation during this phase. Manufacturing conditions, sampling plans, required tests, and data collection are highly recommended to be included in protocol descriptions. 
Process performance qualification should commence after it has been approved by all required departments, in addition to the quality assurance unit.

Process Verification

Developing ongoing monitoring during production to verify that the process remains in a state of control.

  • cGMP guidelines recommend developing procedures to gather and evaluate data relevant to product quality.
  • Following cGMP principles and industry best practices are essential when determining variability.
  • FDA guidelines state that sampling and monitoring in this phase should continue at PPQ established levels until enough data are accumulated to make significant variability estimates.
  • The maintenance of the utilities, facilities, and equipment is also important during this phase. 

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Cleaning and Sterilization Validation

All manufacturers, hospitals, pharmacies, and medical device manufacturers require cleaning and sterilization. We partner with organizations to develop and implement continuously reliable and compliant validation programs that help clients successfully bring products to market.

Our sterilization services include the physical (IQ and OQ) and microbiological inactivation (PQ) testing aspects for steam sterilization, dry heat, and vaporized hydrogen peroxide.

Our cleaning services involve a defined clustering approach of products, protocols, defined assays and limits, protocol writing, in-test lab selection support, execution of testing support, and reporting that result in effective controls for limiting the bioburden.

Good Manufacturing Practices Product Lifecycle Methods

ProPharma knows how to leverage regulatory agencies’ requirements to ensure each phase of your product manufacturing lifecycle is successful.

Our associates include pharmacists, chemists, engineers, and microbiologists, all with industry experience in various aspects of product environments. This experience ensures the analytical techniques used are robust, accurate, and reproducible throughout the product lifecycle. We apply industry knowledge and methodologies to ensure your products provide the expected accuracy and repeatability needed to safeguard them through the manufacturing lifecycle by:

  • Evaluating the reliability of the product analytical methods
  • Determining the methods perform as intended and are reproducible between laboratory and manufacturing sites
  • Partnering with your organization to confirm every aspect of production occurs in a cGMP environment with the necessary controls in place, and evidence of those controls published

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Medical Device

The path for medical devices and diagnostics trials is different from drug development, which is why we have a dedicated team of experts who focus solely on supporting our device and diagnostics clients. Our experts understand what it takes to get these products to market and help design efficient and compliant trials to help meet your goals.

We help our clients navigate the regulatory challenges in both the US and EU associated with devices and diagnostics.

Quality Systems

For medical device manufacturers and their third parties, Quality Management Systems (QMS) are the foundation for enabling the organizations to operate in a compliant manner and provide a strong foundation for business management. The QMS establishes the path to compliance for a company and enables sustainable systems that meet the demands of regulators, customers, and ever-changing business market environments.

We are a trusted partner in designing, building, and managing QMS programs. Our industry-leading experts understand the complex regulatory elements and the compliance systems that are required for your organization to succeed.  We work with all sizes of companies to help design, implement, or remediate a QMS based on business needs and regulatory expectations. We can help guide your team through the regulatory processes specific to your product and provide comprehensive training for your company. We have experience with medical devices, diagnostics, combination product, companion diagnostics and Software as a Medical Device (SaMD). Our experts have industry experience and often prepare and support our clients throughout the audit and approval process.

Our professionals ensure any QMS achieves three objectives:

  • It is appropriate for the phase of development of the product, type of product, and scope of the organization. Understanding your company’s business and resources, we develop a "right-sized" solution that ensures compliance while minimizing burden
  • It establishes the foundation for regulatory compliance and continuous improvement
  • It comprehends the regulatory requirements for all planned markets

Remediation

With our extensive experience with ISO 13485, 21 CFR part 820, and other global regulatory requirements for medical devices and diagnostics, we can support your remediation activities across the entire product lifecycle. Our team supports both proactive remediation projects, like the transition to Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), or reactive remediation projects, such as warning letters, 483s, or other deficiencies identified by other global regulatory bodies.

Explore FDA Form 483 Observation & Warning Letters →

remediation-2

We routinely help clients across the product lifecycle navigate the regulatory frameworks around the world, providing risk management, design control, and technical documentation help to support their products in their target markets. Regardless of whether you need a quality expert to support your team as they work through quality issues or need help strengthening your team as they perform the incremental work to meet the ever-growing compliance expectations for medical devices and diagnostics, we can help.

Medical Devices and Diagnostics Program and Project Management Support

In addition to the traditional program and project management support, we have project managers that have worked extensively within the medical device and diagnostics areas and can help set up a project or program, provide project management resources to support a project or get an existing project back on track. We have deep expertise with clients of all sizes across the entire product lifecycle from early feasibility through design control, submission, launch and post market support; we can provide the project management support to meet the needs of each client.

We also offer an industry-leading, focused workshop utilizing a proven process successfully used over 250 times for medical devices and diagnostics clients. The process takes approximately three weeks to complete and results in a team aligned on the project objectives, a project charter, resource plan and timelines. This approach has been used, for example, to launch a new project or to realign an existing project that may have changed scope or is facing key challenges.

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Quality & Compliance Experts

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Simona Mills

Director
Product Lifecycle Management

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David Crome

Managing Director

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Eric Good

Director
Compliance & Quality Assurance

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Cyril van Erp

Managing Consultant

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Ben Frey

Vice President
Compliance & Quality Assurance

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Deb Bartel

Senior Vice President
Quality Assurance

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June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Infographic Pathways to Market for Medical Devices in the U.S. - ProPharma

October 1, 2023

Pathways to Market for Medical Devices in the U.S.

Medical devices are regulated by the Center for Devices and Radiological Health (CDRH) at the FDA. Which approval pathway is appropriate for your product? You have developed a medical device and are...

Case Study Accelerate European Market Access with Compliant and Comprehensive MAA Submission - ProPharma

October 14, 2021

Accelerate European Market Access with Compliant and Comprehensive MAA Submission

Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Placing a medicinal product in the European market requires a license for...

Case Study An Inspection-Ready QMS Accelerates Product Introductions in Europe - ProPharma

February 3, 2022

An Inspection-Ready QMS Accelerates Product Introductions in Europe

Accessing new market is in the European Union can be a challenge especially when having to navigate both specific country and general European regulation. Read how ProPharma Group used their deep...

Case Study Bespoke Regulatory Sciences Teams for Pharmaceutical Companies - ProPharma

November 30, 2021

Bespoke Regulatory Sciences Teams for Pharmaceutical Companies

Sometimes there is sound logic for a pharmaceutical company to outsource a significant part of their regulatory tasks to a stable and experienced team. ProPharma Group’s team of Regulatory Sciences...

Case Study Outsourcing QA - Reduce Time and Expense While Meeting Critical Requirements - ProPharma

March 18, 2022

Outsourcing QA - Reduce Time and Expense While Meeting Critical Requirements

There is a tendency for VPCs to rely solely on the QC/QA units within their outsourced CMO to perform quality functions. However, the sponsor organization has the ultimate responsibility for product...

Case Study Clinical Monitoring Change Management - ProPharma

October 4, 2021

Clinical Monitoring Change Management

Translating regulatory guidance into success for your organization is difficult when there is not a consistent industry standard. Coupled with new processes and procedures within a company that has a...

Case Study Decentralized Visits in Rare Disease Studies - ProPharma

March 22, 2022

Decentralized Visits in Rare Disease Studies

Learn how ProPharma helped implement and execute decentralized visits for a pediatric rare disease study. The COVID-19 pandemic caused major disruption to many clinical trials and the participants...

Case Study Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area - ProPharma

October 14, 2021

Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area

Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA. You’re developing a drug, biologic, or medical device product. There are a lot of...

Case Study Early Phase Oncology Program in Patients with Solid Tumors - ProPharma

October 1, 2023

Early Phase Oncology Program in Patients with Solid Tumors

See how we helped an emerging Biotech Sponsor achieve an enrollment rate and average time to FPI that is well above industry benchmarks. An emerging Biotech Sponsor needed management and full-service...

Case Study EMA Approval Under Exceptional Circumstances - ProPharma

November 12, 2021

EMA Approval Under Exceptional Circumstances

How we worked with an approved BLA to fit EU requirements for an MAA submission, resulting in EMA approval. You’ve developed a novel drug and obtained FDA approval. Your work is done, right? Not if...

Case Study Ensure Data Integrity Compliance to Prevent Audit Findings - ProPharma

October 1, 2023

Ensure Data Integrity Compliance to Prevent Audit Findings

Ensuring accurate and honest data collection is essential for maintaining the integrity of research. Even though the right mindset is the start of data integrity compliance, that alone is not enough...

Videos Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability - ProPharma

September 1, 2022

Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability

Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response to customer needs. The expectation for higher...

Videos Insider Talks - Tips From Qualified Persons for Successful Importation - ProPharma

June 27, 2022

Insider Talks - Tips From Qualified Persons for Successful Importation

Which are the roadblocks impacting successfully obtaining a MIA for EEA/UK Markets? You are in the process of obtaining an MA or CTA to bring your product to EEA/UK markets, which can be a complex...

Case Study Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence - ProPharma

October 14, 2021

Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence

Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. When considering the acquisition of a new company or product, it...

Case Study Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons - ProPharma

October 14, 2021

Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons

Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...

Case Study EU Medical Device Regulation PMO and Project Delivery  - ProPharma

October 14, 2021

EU Medical Device Regulation PMO and Project Delivery

Regardless of your internal resources, it could be extremely taxing and unrealistic to expect your team to accomplish both their normal daily activities as well as the work necessary to ensure...

Case Study Growing a Culture of Quality and Compliance - ProPharma

November 2, 2021

Growing a Culture of Quality and Compliance

One of the main challenges in adopting a global enterprise quality management system is the complex nature of separate existing tools, applications, and spreadsheets that companies often acquire or...

Case Study How a Two-Part NDA Regulatory Strategy Resulted in Submission Success - ProPharma

October 1, 2023

How a Two-Part NDA Regulatory Strategy Resulted in Submission Success

Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. From ensuring you have...

Case Study How to Ensure Your Multi-Million Dollar Software Launches on Time - ProPharma

October 14, 2021

How to Ensure Your Multi-Million Dollar Software Launches on Time

Launching a large, enterprise technology solution with a global team is a big undertaking for even the most experienced teams and largest companies. Implementing a technology solution of this...

Case Study How to Manage a Drug Product in a Medical Device Environment - ProPharma

June 1, 2022

How to Manage a Drug Product in a Medical Device Environment

A global medical device company asked ProPharma to assess the set-up of the entire supply chain of a drug product. We did so by reviewing the Global Quality Management System and we determined how it...

Case Study How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach - ProPharma

October 4, 2021

How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach

A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...

Case Study How to Successfully Launch Products with QMS and QP Certification - ProPharma

October 14, 2021

How to Successfully Launch Products with QMS and QP Certification

Reaching patients in the EU with needed medicinal products is a complex undertaking that not only requires knowledge of varied regulatory landscapes, companies must also man, the services of a...

Case Study Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline - ProPharma

October 14, 2021

Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline

Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations. Marketing Authorization Holders (MAHs) must perform a risk evaluation...

Case Study Increased Visibility for Senior Management with Custom PMO Design, Implementation - ProPharma

October 4, 2021

Increased Visibility for Senior Management with Custom PMO Design, Implementation

Time. Regardless of company size and the number of products in your portfolio, time is one thing we could all use more of. However, the more projects you have in your portfolio, the more stretched...

Case Study Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days - ProPharma

October 14, 2021

Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days

In May 2020, as the FDA released new guidelines to accelerate the development of novel COVID-19 therapeutics and vaccines, our Clinical Services experts were asked to provide independent Data Safety...

Case Study Laboratory Informatics with Robotics - ProPharma

October 4, 2021

Laboratory Informatics with Robotics

Workflows between Electronic Lab Notebooks (ELNs), Laboratory Information Management Systems (LIMS), Scientific Data Management Systems (SDMS), instruments, and robotics are immensely complex and...

Case Study Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance - ProPharma

October 14, 2021

Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance

When performing initial qualification audits, it’s important to evaluate all critical systems evenly to ensure compliance. Lack of evaluation of all critical systems can leave Sponsors and their...

Case Study Managing Complex Pharmaceutical Projects - ProPharma

October 4, 2021

Managing Complex Pharmaceutical Projects

There are many obstacles your team may face during product development. One of the hurdles includes project management struggles associated with having too many decision makers. Although it is one...

Case Study MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction - ProPharma

October 14, 2021

MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction

A routine safety letter to healthcare professionals (HCPs) was misinterpreted by recipients, causing a “recall-like” crisis event for a multinational pharmaceutical client. When a routine safety...

Case Study Navigating QMS Requirements from a Medical Device Perspective - ProPharma

April 12, 2022

Navigating QMS Requirements from a Medical Device Perspective

Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under...

Videos Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life - ProPharma

October 1, 2023

Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life

In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In...

Case Study Overworked Medical Device Teams Missing Deadlines - ProPharma

October 14, 2021

Overworked Medical Device Teams Missing Deadlines

Is your company experiencing rapid growth? Is your team overworked and falling further and further behind? ProPharma Group’s team can help. You may recognize that this is happening but not...

Videos Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective - ProPharma

May 19, 2022

Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective

As businesses face the shared global challenges of adapting to new operating models triggered by the recent pandemic, regulated drug and device sponsors, marketing authorization holders, and...

Case Study Program and Project Management Effectively Deliver a QMS Optimization Program - ProPharma

April 25, 2022

Program and Project Management Effectively Deliver a QMS Optimization Program

Given the challenging scheudules and competing priorities, companies have minimal time to proactively address optimization of their QMS. There's very little time for addressing prioritized...

Videos Insider Talks - To Decentralize or Not to Decentralize … That is the Question - ProPharma

March 25, 2022

Insider Talks - To Decentralize or Not to Decentralize … That is the Question

Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...

Case Study Reduced Burden for Oncology Patients With Decentralized Visits - ProPharma

March 21, 2022

Reduced Burden for Oncology Patients With Decentralized Visits

Learn how our team helped implement decentralized visits for an oncology study that reduced patient burden and stress on the sites. Oncology studies often require frequent sample collection visits....

Videos AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability - ProPharma

February 4, 2022

AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability

AI can enable MI Contact Centers to transform the customer experience using digital avenues. Join us for our upcoming Insider Talks to find out!

Case Study Secure Timely Product Launch by Ensuring GDP Compliance Across Europe - ProPharma

October 14, 2021

Secure Timely Product Launch by Ensuring GDP Compliance Across Europe

Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...

Case Study Sponsor Successfully Completes Acquisition After Efficient PMA Submission - ProPharma

July 26, 2022

Sponsor Successfully Completes Acquisition After Efficient PMA Submission

A major Top 10 Medical Device Sponsor engaged M2, a ProPharma Group company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. Learn how...

Case Study Statistical Analytics with Machine Learning Tool Enablement - ProPharma

October 14, 2021

Statistical Analytics with Machine Learning Tool Enablement

Introducing new tools is difficult and comes with a learning curve for even the most experienced, and having clearly defined processes and procedures is critical to your team’s success. If there is...

Videos 20 Years of Improving Patient Health and Safety - ProPharma

January 25, 2022

20 Years of Improving Patient Health and Safety

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Case Study Supporting Decentralized Gene Therapy Visits - ProPharma

February 17, 2022

Supporting Decentralized Gene Therapy Visits

Clinical trials often require frequent visits to the investigative site and procedures which can be a turn-off or become the reason many patients cannot commit their time to participate in a study....

Videos Cohort Management Process and Planning: Challenges, Risks, and Mitigations - ProPharma

December 7, 2021

Cohort Management Process and Planning: Challenges, Risks, and Mitigations

Learn novel and useful drug design methodologies based on ProPharma Group's years of experience navigating the risks, issues, and difficulties associated with various cohort design studies.

Videos Expedited Programs Explained: How to Expedite Product Approval in the US and Europe - ProPharma

November 12, 2021

Expedited Programs Explained: How to Expedite Product Approval in the US and Europe

Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find out!

Case Study Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors - ProPharma

October 14, 2021

Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors

Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...

Videos What Does it Take to Build a Legacy? (20th Anniversary Video) - ProPharma

October 15, 2021

What Does it Take to Build a Legacy? (20th Anniversary Video)

Case Study Understanding Clinical Trial Requirements for Medical Device Label Extensions - ProPharma

October 14, 2021

Understanding Clinical Trial Requirements for Medical Device Label Extensions

After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...

Case Study Using Science to Achieve EMA Approval for a First-in-Class Indication - ProPharma

October 14, 2021

Using Science to Achieve EMA Approval for a First-in-Class Indication

See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic. You’re developing a drug, biologic, or medical device product. Your...

Videos The True Cost of Non-Compliance - ProPharma

October 13, 2021

The True Cost of Non-Compliance

How to avoid getting your first, second, and third warning letter from a federal agency.

Case Study When a Team Lacks Industry Experience - ProPharma

October 14, 2021

When a Team Lacks Industry Experience

Working with a team from three organizations across the globe is hard. Unifying them required experts to take the lead. Working with a team that is spread across the globe and made up of people from...

Case Study When a Team Loses Their Leader and Lacks a Plan - ProPharma

October 14, 2021

When a Team Loses Their Leader and Lacks a Plan

Projects spanning multiple functions across an organization can be difficult to execute and require the leadership of an experienced and organized project manager. But what happens if the project...

Videos ProPharma Group Overview Video  - ProPharma

October 4, 2021

ProPharma Group Overview Video

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Guide Assess Your Readiness for Supplying Drug Product to Europe and UK

June 16, 2023

Evaluate Readiness and Compliance for Supplying Drug Product to EU/UK/EEC

Assessing your progress is of utmost importance when supplying pharmaceutical products to the European Union (EU), United Kingdom (UK), and European Economic Community (EEC), as it ensures compliance...

Whitepapers Meeting the FDA's CAPA Expectations - ProPharma

March 21, 2022

Meeting the FDA's CAPA Expectations

Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical...

Whitepapers What You Need to Know About Regulatory Programs for Expedited Approval - ProPharma

October 1, 2023

What You Need to Know About Regulatory Programs for Expedited Approval

Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

Flyers EU IVDR Progress Self Assessment - ProPharma

February 3, 2022

EU IVDR Progress Self Assessment

The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.

Flyers EMA Services: Ensure Regulatory Success - ProPharma

October 14, 2021

EMA Services: Ensure Regulatory Success

Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)

Flyers Accelerating Your Product Through Drug Development - ProPharma

October 1, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers Cell and Gene Therapy Center of Excellence - ProPharma

October 14, 2021

Cell and Gene Therapy Center of Excellence

Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients

Flyers Data Integrity: The Quality of Your Product Depends on The Quality of Your Data - ProPharma

October 14, 2021

Data Integrity: The Quality of Your Product Depends on The Quality of Your Data

Regulatory Agencies Expect Controls to Be in Place

Flyers FDA Consulting: Regulatory Strategy Expertise - ProPharma

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers ProPharma Group Services Overview - ProPharma

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers Medical Device Development

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers EU Market Access: Accelerate Market Access to Europe with MIA License

October 4, 2021

EU Market Access: Accelerate Market Access to Europe with MIA License

Reduce Launch Timeline and Improve Business Efficiency

Flyers Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

October 1, 2023

Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

Save Time and Boost your Bottom Line

eBook Outsourcing of Medical Information Content Creation: Experience of 100 Clients

October 17, 2021

Outsourcing of Medical Information Content Creation: Experience of 100 Clients

The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

Whitepapers Good Science Presented Well Generates Approval

October 14, 2021

Good Science Presented Well Generates Approval

Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest...

Whitepapers How to Compile a Science-Backed New Drug Application (NDA) Submission

October 14, 2021

How to Compile a Science-Backed New Drug Application (NDA) Submission

Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips. You are getting ready to...

Whitepapers A Guide for Efficacious Data Integrity During COVID-19

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

Learn how ProPharma Group implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains,...

eBook Evolving EMEA MI Service Models

October 14, 2021

Evolving EMEA MI Service Models

There are 116 countries in the EMEA region and around 24 languages spoken, how do you know what structure and model are best for each client and how do you go about making it happen? There are so...

Whitepapers What You Need to Know About GxP Independent Compliance Audits

October 13, 2021

What You Need to Know About GxP Independent Compliance Audits

Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. Prevent the consequences of quality systems being...

eBook Outsourcing Medical Information Services: When to Consider a Dedicated Resource

October 4, 2021

Outsourcing Medical Information Services: When to Consider a Dedicated Resource

Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...

eBook Improving Product Quality During Technical Transfers

October 4, 2021

Improving Product Quality During Technical Transfers

Is your product quality at risk during a tech transfer? Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and...

Guide 6 Key Elements of Successful Drug & Device Development in Europe

March 31, 2023

6 Key Elements of Successful Drug & Device Development in Europe

Challenges of Complying with EMEA and Country-specific Regulations Navigating EMEA and Country-specific regulations is both confusing and a mammoth task. The EU regulatory system has around 50...

Case Study CMC Program Management Case Study

March 24, 2023

CMC Program Management

Learn how a biotech company sought help from ProPharma for the CMC section of their CAR T-cell therapy program. An experienced CMC program management consultant developed and facilitated a product...

Case Study Drug Development Program Management Case Study

March 24, 2023

Drug Development Program Management

Discover how ProPharma assisted a biotech company who needed help with drug development program management, NDA and MAA filing for their immuno-oncology products. ProPharma provided an experienced...

Case Study Medical Affairs Case Study

March 24, 2023

Medical Affairs

Explore how ProPharma helped a large pharmaceutical company who needed more medical affairs leaders for scientific and project management expertise for their rapidly growing medical affairs...

Case Study Medical Safety Scientist Case Study

March 24, 2023

Medical Safety Scientist

This case study outlines the successful collaboration between a pharmaceutical company's medical safety department and an experienced ProPharma safety scientist who was able to handle a spike in...

Case Study Quality and Analytical Scientist Case Study

March 24, 2023

Quality and Analytical Scientist

Learn how ProPharma partnered with a pharmaceutical company who experienced a spike in demand for quality and analytical scientists, necessitating the need for an experienced consultant to take...

Case Study Regulatory Affairs Project Manager Case Study

March 24, 2023

Regulatory Affairs Project Manager

The regulatory affairs department of a biotech company faced a challenge in meeting regulatory filings for important company deadlines, and sought ProPharma’s help. As a result, the client was able...

Case Study SOPs and Processing Mapping Case Study

March 24, 2023

SOPs and Processing Mapping

This case study outlines how a biotech company struggling with compliance and a lack of standard operating procedures (SOPs) turned to ProPharma for help. The consultant recommended a process mapping...

Case Study Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

March 29, 2023

Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

Scaling resources for clinical trials can be a daunting task, especially when demands fluctuate over time. In this case study, a sponsor faced several challenges related to resource allocation and...

Guide 6 Things to Consider When Selecting a Research Platform

April 6, 2023

6 Things to Consider When Selecting a Research Platform

Unlocking the Full Potential of Your Life Science Organization: Investing in Digital Initiatives As a leader in the life sciences industry, we know that data is one of the most valuable assets for...

Whitepapers Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

May 3, 2023

Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...

Guide Maximizing Patient Outcomes. A Contact Center Needs Assessment.

May 16, 2023

Maximizing Patient Outcomes. A Contact Center Needs Assessment.

Unlock the secrets to designing effective patient support programs with our invaluable guide. By embracing a patient-focused approach and utilizing our comprehensive contact center checklist, you can...

Whitepapers 5 Key Challenges in the Development of Cell & Gene Therapy

May 24, 2023

5 Key Challenges in the Development of Cell & Gene Therapy

Challenges in Cell and Gene Therapy Development Developing and bringing Cell and Gene Therapy (CAGT) products to market comes with significant challenges. This whitepaper focuses on the key obstacles...

Case Study FSP models for IVD Clinical Trials:  Meeting Growing Pipeline Demands

June 12, 2023

FSP models for IVD Clinical Trials: Meeting Growing Pipeline Demands

Streamlining Clinical Trial Operations: How the FSP Model Transformed a Mid-Sized Biotech Company's Success. In this case study, we delve into the experience of a mid-sized genetic testing and...

Flyers Functional Service Provider (FSP) Value Proposition

June 21, 2023

Functional Service Provider (FSP) Value Proposition

At ProPharma, we forge strategic partnerships with our clients to collaboratively devise optimal strategies and drive remarkable results and operational excellence. With our cutting-edge FSP...

Flyers Labeling Development & Intelligence

June 21, 2023

Labeling Development & Intelligence

Our cutting-edge labeling intelligence solution at ProPharma empowers our highly skilled labeling development consultants to offer an unmatched product development strategy and top-tier labeling...

Case Study Enhancing Site Capacity for Clinical Trials with DCT Nurses

June 27, 2023

Enhancing Site Capacity for Clinical Trials with DCT Nurses

Discover how ProPharma helped a US biotech company focused on rare neurologic conditions overcome challenges in securing qualified resources for their study sites. Our FSP solutions, featuring study...

Whitepapers Compliance Auditing: Diving into Common Critical Findings

July 31, 2023

Compliance Auditing: Diving into Common Critical Findings

Compliance Auditing: Diving into Common Critical Findings Discover the crucial role of compliance auditing in the healthcare industry with our in-depth whitepaper, now available for download. Our...

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