<iframe src="https://www.googletagmanager.com/ns.html?id=GTM-WR9VRVQ" height="0" width="0" style="display:none;visibility:hidden">

gxp audits, consulting & inspections

Servicing All GxPs Across All Regulatory Phases
GxP Audits Header GxP Audits Header
quality-compliance

1,000+ Audits Performed in the Last Two Years

patient-support-programs

200+ Clients Served in the US and Internationally

global-submissions

350+ Compliance Auditors Located in 30+ Countries

authority-meetings

33 Languages Supported

Colorized half circle.
Male GxP auditor standing with arms crossed wearing grey jacket

Global Auditing Program

Auditing is an integral part of the GxP landscape as companies must be compliant with regulatory requirements to move to the next phase of development and maintain their place in the market. ProPharma serves as an extension of your clinical and commercial quality departments, collaborating closely to evaluate internal and vendor systems for compliance and quality improvements. 

Enhance your quality and compliance journey with our global team of dynamic auditors. Whether you require single audits or comprehensive vendor management programs, we deliver bespoke audit support that meets your specific needs. Our expertise spans across all regulatory lifecycle stages, ensuring alignment with the latest industry trends, evolving regulations, and standards in GxP auditing.

Audit Services

With a wealth of experience, our auditors specialize in conducting a wide range of audits and assessments. From comprehensive compliance audits to assisting with health authority inspections and pre-approval preparations, we provide comprehensive support throughout the audit process.

With offices and compliance consultants located around the world, ProPharma offers the capability to execute audits in different GxP areas on a global scale, creating efficiency and savings. Our large team of qualified auditors has a breadth of expertise across the entire development and regulatory spectrum, including the European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), United States Food and Drug Association (FDA), Japan Pharmaceuticals and Medical Devices Agency (PDMA), Health Canada, ISO-13485, ISO-9001, CAP/CLIA, Computer Systems Validation (CSV), Digital Compliance Audits, and Data Integrity.

ProPharma's team of experts excels in identifying potential areas of improvement, enhancing compliance, and optimizing your operations in alignment with regulations and industry best practices. Our comprehensive approach and expert knowledge ensure that your organization maintains the highest standards of quality and regulatory compliance across the GxP landscape.

Vendor Audits

Good Manufacturing Practice (GMP) Audits

We offer comprehensive cGMP (Current Good Manufacturing Practice) compliance audits tailored to your specific needs, whether it's for an initial qualification of your vendor or recurring audits. Our highly experienced team conducts audits with a focus on independence and impartiality, providing you with valuable insights and actionable recommendations for improvement. We specialize in conducting audits across various GMP industries, including:

  • Drug product/drug substance
  • Devices and components
  • Excipients and raw materials
  • GDP – warehouse and distribution
  • GMP laboratories
professional-looking-at-two-monitors-with-data-and-graphs

Good Clinical Practice (GCP) Audits

ProPharma's GCP (Good Clinical Practice) Auditors specialize in conducting thorough and comprehensive GCP Audits, offering assurance that your clinical studies, whether ongoing or planned, are conducted in compliance with regulatory requirements. Our audits provide valuable insights and recommendations to ensure clinical study compliance success. We focus on various key areas, including:

  • Clinical Research Organization (CRO)
  • Investigator Sites
  • Trial Master Files (TMF)
  • Good Clinical Laboratory Practice (GCLP)

IT Vendor Audits

Regulators require assessment and approval for suppliers of critical software applications, IT infrastructure, and IT support services.  ProPharma has the expertise to assess system functionality and vendors’ quality management practices for compliance with regulations such as Part 11 and Annex 11. Additionally, we assess your IT vendor’s SDLC and testing methodologies so you will have the documentation to support your computer system validation strategy.  Our audit services include:

  • Software, SaaS, and PaaS vendor audits
  • IT infrastructure and IaaS vendor audits 
  • IT service and validation provider vendor audits

Good Laboratory Practice (GLP) Audits

ProPharma specializes in conducting comprehensive GLP (Good Laboratory Practice) Audits, ensuring that pre-clinical and clinical laboratory activities are appropriately managed and comply with regulatory requirements. Our audits cover a wide range of areas, including animal studies, toxicological assessments, pharmacokinetics (PK) studies, and clinical laboratory specimen testing. Our experienced auditors identify potential areas for improvement, ensure the welfare of laboratory animals, and verify the accuracy and reliability of laboratory data. We focus on various key components of GLP auditing, including:

  • Nonclinical labs
  • Animal use and care

Postmarket Surveillance Audits

ProPharma's Postmarket Surveillance Audits evaluate the intake of drug and device safety data, compliance with reporting requirements, and adherence to timelines. Our audits focus on key areas within post-market surveillance, and our team provides detailed assessments to ensure regulatory compliance and enhance patient safety. Our expertise covers the following aspects:

  • Pharmacovigilance (PV)
  • Complaint management
  • Digital Information and Internet Systems (IT/IS)


Request a GxP Audit

Inspection Readiness

professionals-looking-at-whiteboard

Our inspection readiness auditing encompasses pre-approval inspection (PAI) readiness or mock inspection and gap analysis prior to the inspection by a regulatory agency. Our team of inspection readiness auditors has experience with over 60 regulatory inspections undertaken by various agencies including the MHRA (UK), HPRA (Ireland), EMA, SUKL (Czech Republic), FDA (US), Korean FDA, Turkish MOH, MCC South Africa, Anvisa Brazil, at sites in Argentina, Bangladesh, Czech Republic, England, India, Nordics, Belgium, Germany, The Netherlands, Switzerland, and Ireland. 

Our Inspection Readiness Services Include:

  1. Pre-Approval Regulatory Inspections in all GxP areas: Ensuring your organization is fully prepared for regulatory assessments
  2. Mock Regulatory Inspections in all GxP Areas: Practicing simulated inspections to identify and address potential issues proactively.
  3. Guidance on Corrective Actions: Providing insight into necessary corrective actions and validations before the regulatory inspection, avoiding potential non-compliance citations.
  4. Training for Successful Regulatory Inspection: Preparing your team for interviews, interactions, and best practices during regulatory agency visits.
  5. Inspection Readiness Reviews: Crucial, especially with the increasing frequency of unannounced inspections.
  6. Compliance-Level Review for License Applications: Assessing compliance with best practice standards for obtaining or retaining essential licenses like Manufacturer's/Importation Authorisation (MIA), Wholesale Distributor Authorisation (WDA), Marketing Authorization (MA), GMP, and GDP.

Ensure your organization is inspection-ready with our comprehensive audit services, tailored to meet your GxP compliance needs and ensure seamless interactions with regulatory agencies.

Speak to an Inspection Expert

Quality Management System Gap Assessments

Providing a risk-based "right-sized" approach, our compliance experts evaluate the current state of an organization’s Quality Management System for compliance with regulatory requirements and best industry practices. Our compliance experts will seamlessly integrate with your team to do more than simply identify potential risks. We provide recommendations to mitigate those risks and can work side-by-side with you to implement improvement plans and support your staff in addressing those risks. 

Request an Audit

Data Integrity Gap Assessments

ProPharma assesses real-world situations vs. the principles of ALCOA to identify data integrity risks. We have drawn from international regulations, regulatory guidance documents, FDA Warning Letters, and decades of professional experience to develop comprehensive tools for assessing policies, procedures, and systems to detect data integrity risks.  Our standardized approach to performing data integrity gap assessments encompasses the requirements documented by the US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA.

Our mission is to provide the information you need to mitigate data integrity risks before your organization has a data integrity issue. 

Other Audit Services

Professionals around conference table smiling pointing at papers with data graphs

Return To Service Audits

When our clients seek assistance in remedying regulatory agency actions, such as a warning letter, ProPharma recommends a multi-stage approach. Warning letters are typically issued by agencies when they perceive a lack of control in healthcare products manufacturing. As part of the remediation process, the company is expected to evaluate the state of compliance across the entire organization and remediate all observed compliance issues. ProPharma’s approach involves conducting comprehensive GMP Baseline Assessments across 31 Quality System Elements (QSE) that roll up to the six-systems inspection methodology. 

Due Diligence

ProPharma's Quality & Compliance team possesses extensive expertise in conducting Due Diligence audits for firms undergoing mergers or acquisitions. These audits involve comprehensive assessments of the target companies' quality systems to evaluate their current state and provide a thorough measure of the risk associated with potential compliance faults.

Our auditors carefully examine various aspects of the target company's operations, including quality management systems, standard operating procedures, documentation practices, training programs, and regulatory compliance records. By conducting these assessments, we enable clients to gain a comprehensive understanding of the target company's compliance status, potential risks, and areas that require remediation.

We focus on identifying any compliance gaps or deficiencies that may impact the integration process. Working collaboratively with our clients, we develop effective mitigation strategies. Leveraging our expertise and attention to detail, we assist our clients in mitigating compliance risks, optimizing their due diligence process, and ensuring a seamless transition during mergers or acquisitions.

Internal Audits

Our experienced auditors can also help companies evaluate and improve their internal controls and compliance. We review policies, procedures, and documentation, analyze risk management practices, and conduct interviews with key personnel. We collaborate closely with clients, offering actionable recommendations and assisting with corrective action plans. With ProPharma's expertise, organizations can strengthen their internal processes and achieve operational excellence.

Request an Audit

Our GxP Audit Approach

ProPharma's Quality & Compliance consultants provide a foundation of quality expertise across the landscape of regulatory expectations. We bring established quality processes to quickly navigate compliance solutions and assessment of risk to help identify, build, and maintain compliance to the ever-changing regulatory expectations. Our dedicated team of subject matter experts works to ensure that each individual project is successful.

Audit Preparation

Audit Execution

Post Audit Deliverables

Audit Coordination Team

Each client is aligned with a dedicated Audit Coordinator, serving as the point of contact who will facilitate the management of audit logistics, periodic progress meetings, timelines, and completion of deliverables between client/sponsor, auditor, and auditee.

We'll also assign a subject matter expert (SME) compliance consultant who will serve as technical support for audit process and peer review of deliverables and outputs.

GxP Auditor

Assigned on a per audit basis, we’ll match you with an auditor who has the background, experience, and expertise aligned with the audit scope, geographic location, and project timing.

The assigned auditor(s) will be trained on any relevant Standard Operating Procedures (SOPs) of the client when requested.

Audit Preparation

Audit scope and timelines will be agreed upon with the client. As required, Sponsor procedures and templates may be used for audit preparation, conduct, and follow-up.

A briefing meeting to ensure full alignment with client in case of specific requirements may be part of the preparations.

An Agenda / Plan will be developed to formally agree upon the audit details (purpose, scope, criteria, activities, etc.) with client.

Virtual / On-site Audits

ProPharma has extensive experience performing both in-person and virtual audits. In the event of virtual audits, our audit coordination team provides an additional level of technical support to ensure that document sharing, application access, and web conferencing are aligned prior to audit onset to avoid delays.

Audit Scheduling

ProPharma utilizes a validated audit scheduling database to ensure that all audits and deliverables are managed to client timelines and expectations.

The audit dates and plan will be confirmed with the vendor (e.g., Clinical Research Organizations (CRO), laboratory, manufacturer, etc.).

For preparation purposes, some documents may be requested from the site and/or Client prior to the assessment.

Audit Execution

During the Audit Execution phase, we execute the audit according to the agenda/plan. This includes reviewing roles and responsibilities, conducting facility tours, interviews, material reviews, and daily debrief meetings.

We analyze observations, make recommendations, and identify areas of positive performance.

Our auditors follow a specific audit execution methodology for the appropriate GxP type and lifecycle stage.

Peer Review

ProPharma's team of compliance consultants will perform a technical and quality peer review of all deliverables prior to submittal to the client to ensure consistency and compliance accuracy.

Deliver Final Report

A final report will be drafted based on a pre-determined format agreed upon with the client.

Debrief Meeting

A debriefing meeting with the Client following the assessment may be part of the arrangements.

Deficiency Classification

Deficiencies are typically categorized as critical, major, or minor. Comments or recommendations may be included in the report, including recommendations to ensure compliance or inspection readiness of the auditee. The responsibility for addressing the finding (sponsor/CRO, investigator, vendor, etc.) may also be included.

Post Audit Support & CAPA Management

ProPharma offers Post Audit Support and CAPA Management services to assist clients in resolving CAPA items identified during audits. Our expert consultants provide administrative support by tracking and compiling CAPA commitments, conducting auditor adequacy reviews, and offering CAPA remediation assistance. We ensure regulatory compliance, address root causes, and drive continuous improvement.

Audit Preparation

Click here to expand this section

Audit Coordination Team

Each client is aligned with a dedicated Audit Coordinator, serving as the point of contact who will facilitate the management of audit logistics, periodic progress meetings, timelines, and completion of deliverables between client/sponsor, auditor, and auditee.

We'll also assign a subject matter expert (SME) compliance consultant who will serve as technical support for audit process and peer review of deliverables and outputs.

GxP Auditor

Assigned on a per audit basis, we’ll match you with an auditor who has the background, experience, and expertise aligned with the audit scope, geographic location, and project timing.

The assigned auditor(s) will be trained on any relevant Standard Operating Procedures (SOPs) of the client when requested.

Audit Preparation

Audit scope and timelines will be agreed upon with the client. As required, Sponsor procedures and templates may be used for audit preparation, conduct, and follow-up.

A briefing meeting to ensure full alignment with client in case of specific requirements may be part of the preparations.

An Agenda / Plan will be developed to formally agree upon the audit details (purpose, scope, criteria, activities, etc.) with client.

Audit Execution

Click here to expand this section

Virtual / On-site Audits

ProPharma has extensive experience performing both in-person and virtual audits. In the event of virtual audits, our audit coordination team provides an additional level of technical support to ensure that document sharing, application access, and web conferencing are aligned prior to audit onset to avoid delays.

Audit Scheduling

ProPharma utilizes a validated audit scheduling database to ensure that all audits and deliverables are managed to client timelines and expectations.

The audit dates and plan will be confirmed with the vendor (e.g., Clinical Research Organizations (CRO), laboratory, manufacturer, etc.).

For preparation purposes, some documents may be requested from the site and/or Client prior to the assessment.

Audit Execution

During the Audit Execution phase, we execute the audit according to the agenda/plan. This includes reviewing roles and responsibilities, conducting facility tours, interviews, material reviews, and daily debrief meetings.

We analyze observations, make recommendations, and identify areas of positive performance.

Our auditors follow a specific audit execution methodology for the appropriate GxP type and lifecycle stage.

Post Audit Deliverables

Click here to expand this section

Peer Review

ProPharma's team of compliance consultants will perform a technical and quality peer review of all deliverables prior to submittal to the client to ensure consistency and compliance accuracy.

Deliver Final Report

A final report will be drafted based on a pre-determined format agreed upon with the client.

Debrief Meeting

A debriefing meeting with the Client following the assessment may be part of the arrangements.

Deficiency Classification

Deficiencies are typically categorized as critical, major, or minor. Comments or recommendations may be included in the report, including recommendations to ensure compliance or inspection readiness of the auditee. The responsibility for addressing the finding (sponsor/CRO, investigator, vendor, etc.) may also be included.

Post Audit Support & CAPA Management

ProPharma offers Post Audit Support and CAPA Management services to assist clients in resolving CAPA items identified during audits. Our expert consultants provide administrative support by tracking and compiling CAPA commitments, conducting auditor adequacy reviews, and offering CAPA remediation assistance. We ensure regulatory compliance, address root causes, and drive continuous improvement.

Meet Our GxP Experts & Consultants

James Meckstroth

James Meckstroth

Director, Compliance & Quality Assurance

Laurie Rouse

Laurie Rouse

Global Audit Coordination Manager

Catrin Jones

Catrin Jones

Consultant, Compliance and Quality Assurance

Matt Hermon

Matt Hermon

Principal Compliance Consultant

Gradient Image

Customized Strategy. Globally Scaled Solutions.

ProPharma's ability to execute audits in different GxP areas on a global basis with diverse language skills creates efficiencies in both time and money. Our experienced team of qualified auditors from around the world is here to support the entire development and regulatory spectrum.

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 report takes an insightful look at the common critical audit findings noted by Health Authorities and our expert GxP Compliance Auditors, reinforcing the indispensable need for healthcare companies to follow stringent standards laid down by prominent global regulatory bodies.

Download: Compliance Auditing: Diving into Common Critical Findings

compliance-auditing-whitepaper

 

News & Insights

FDA Regulatory Sciences The Impact of a US Government Shutdown on the Food and Drug Administration

September 27, 2023

The Impact of a US Government Shutdown on the Food and Drug Administration

U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

Quality & Compliance Medical Information DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

September 25, 2023

DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

Meet the Expert Medical Information Meet the Expert: Kamila Rocha

September 21, 2023

Meet the Expert: Kamila Rocha

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Press Releases ProPharma Appoints Alena Hammond as Global Head of Clinical Operations

September 27, 2023

ProPharma Appoints Alena Hammond as Global Head of Clinical Operations

Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI

September 13, 2023

ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI

Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho

August 30, 2023

ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho

RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

May 3, 2022

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

April 21, 2022

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

Congratulations to our 2015 Colleague Award Winners!

December 21, 2015

Congratulations to our 2015 Colleague Award Winners!

Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...

Infographic The Cost of Poor Project Management - ProPharma

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...

News & Insights

Press Releases ProPharma Appoints Alena Hammond as Global Head of Clinical Operations

September 27, 2023

ProPharma Appoints Alena Hammond as Global Head of Clinical Operations

Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI

September 13, 2023

ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI

Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho

August 30, 2023

ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho

RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Previous Post Arrow Next Post Arrow
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

May 03, 2022

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

April 21, 2022

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

Congratulations to our 2015 Colleague Award Winners!

December 20, 2015

Congratulations to our 2015 Colleague Award Winners!

Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...

Previous Award Arrow Next Award Arrow
FDA Regulatory Sciences The Impact of a US Government Shutdown on the Food and Drug Administration

Sep 27, 2023 11:57:42 AM

The Impact of a US Government Shutdown on the Food and Drug Administration

U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

Quality & Compliance Medical Information DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

Sep 25, 2023 4:59:00 PM

DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

Meet the Expert Medical Information Meet the Expert: Kamila Rocha

Sep 21, 2023 7:00:00 AM

Meet the Expert: Kamila Rocha

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

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

September 28, 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

September 28, 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

September 28, 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

September 28, 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

September 28, 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

September 28, 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

September 28, 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)

September 28, 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...

Previous Resource Arrow Next Resource Arrow