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.

 

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 auditors have real world experience supporting regulatory inspections and preparing companies for pre-approval inspections.

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.).

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 Market Access

Navigating both the specific country and general European regulations and requirements to gain access to European markets can be a complex challenge. On top of the varying requirements, Sponsors looking to enter the European markets must create tailored market access strategies per country and establish a legal entity with a Qualified Person (QP) in the region. All of which can be extremely difficult for even the most experienced individuals.

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's EU and UK Manufacturing and Import Licenses (MIAs) allows us to help clients overcome the complexities of accessing the EU and UK markets, like navigating country and EU regulations, creating tailored strategies per country, and supports the Sponsor’s need 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.

ProPharma can perform QP Batch Certification services under its own MIA license for pharmaceutical and biotech clients launching products to the European (Schengen countries) and UK markets, as well as release for export from the European and UK market (e.g., to the United States) and release of existing products.


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Quality Assurance, Qualified Person (QP), and Responsible Person (RP)

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, import, sell, or distribute pharmaceutical products in the EU and UK require an MIA license and a designated QP 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, market access, and supply for clinical trials.

Each Wholesaler Dealer Authorization (WDA) has a Responsible Person (RP) named on the license. 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.

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.

remediation

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.

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.

 

vendor-selection

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.

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.

 

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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

simona mills headshot

Simona Mills

Director
Product Lifecycle Management

david crome headshot

David Crome

Managing Director

eric good headshot

Eric Good

Director
Compliance & Quality Assurance

cyril van erp headshot

Cyril van Erp

Managing Consultant

ben frey headshot

Ben Frey

Vice President
Compliance & Quality Assurance

deb bartel headshot

Deb Bartel

Senior Vice President
Quality Assurance

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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

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

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

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

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

February 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

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

June 1, 2022

How to Manage a Drug Product in a Medical Device Environment

A global medical device company asked ProPharma Group 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...

Case Study

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

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

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

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

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

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

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

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

October 14, 2021

MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction

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

Case Study

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

February 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

October 15, 2021

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

Case Study

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

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

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

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

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

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.  

Flyers

August 8, 2022

QP MIA Survey - Progress Self-Assessment

Use this readiness questionnaire to assess the current state of your progress.

Whitepapers

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

February 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

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

October 14, 2021

EMA Services: Ensure Regulatory Success

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

Flyers

February 1, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers

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

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

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers

October 4, 2021

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

Reduce Launch Timeline and Improve Business Efficiency

Flyers

February 1, 2023

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

Save Time and Boost your Bottom Line

eBook

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

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

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

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

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

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

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

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...

Complex Needs Require Custom Solutions

ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.