RCO solutions
Our fit-for purpose global solutions span across the full product lifecycle.

The World's Largest RCO
ProPharma offers a suite of fully customizable consulting solutions across service lines and functional areas of expertise. We collaborate with clients to co-create optimal solutions, build sustainable and scalable operating models, operationalize robust execution, and position our clients for development and growth.
Product Lifecycle
Domain Expertise

Select from a comprehensive array of full product lifecycle services to create a fit-for-purpose solution. These services by design, operate autonomously in a model that can be engaged individually to help with a specific need or assembled into an integrated end-to-end construct that can flex up or down in scope/scale as programs evolve. Our deep domain expertise helps you solve your most complex research problems across the following areas:
- Strategic Consulting
- R&D Information Technologies
- Biostatistics & Data Science
- Regulatory Sciences
- Rare Disease & Orphan R&D
- Cell & Gene Therapy
- Peri/Post-Approval
Global Solutions

Our fit-for-purpose global solutions span across the full product life cycle with a team of experts who bring a comprehensive portfolio of services to help solve complex challenges in a dynamic environment. ProPharma’s global expertise includes:
- Clinical Research Services
- Regulatory Operations
- Medical Information
- Pharmacovigilance
- Quality and Compliance
The Future of Research Consulting is Here
We’ve revolutionized the traditional model and put our clients at the very center. Our new system delivers better solutions and completely redefines what’s possible for you and your organization.
Client Feedback
"The ProPharma Group has been a valued and trusted partner as our Medical Information third party call center for a number of years. During that time they have exhibited the highest level of quality, compliance, and professionalism. Always keeping the needs of our mutual customers front and center. The team is diverse in their staff and their offered services, which enables us to customize support to business need. We would highly recommend the services of ProPharma without hesitation.”
Laurie Wingett - Bayer, Inc.
Medical Affairs Head, Primary Care (WH/established brands) and Medical Operations
“Working with Pro Pharma has been a pleasure. The auditors are friendly, knowledgeable, and communicative. They have been a great resource to help us complete a wide range of audits and
manage our supplier quality.”
Emily King - Azurity Pharmaceuticals
"Working with the whole team at ProPharma Group has been an honor. For several years they have acted on our behalf as a trusted customer facing vendor for medical information inquiries. their subject matter expertise, collaborative nature and high level of professionalism have been a bellwether for us through all stages of marketing and scaling a new drug product. The next time my team is in need of scientific communication outsourcing, PPG will be my first stop."
Jenny Strauss - Biohaven Pharmaceuticals
Manager, Medical Information and Communications
“Lyell engaged Pro Pharma as our validation partner as we built and qualified the LyFE Manufacturing Center. Pro Pharma assisted in all phases of the qualification including establishing the facility and equipment qualification program, protocol generation, protocol execution, and writing the final reports. They played a critical role in getting the facility ready on time and on budget to support the Lyell clinical trials.”
David Shank - Lyell Immunopharma, Inc.
Vice President, Manufacturing
When we partnered with Oxford University to enable global development, manufacturing and distribution of our vaccine, we put broad and equitable access at the heart of our response. The result was a vaccine that was developed in under a year, and we believe we have made a significant impact in terms of global public health. Based on data published in The Lancet and an analysis by Airfinity, our vaccine is estimated to have saved over 6 million lives in the first year of vaccination.
AstraZeneca supplied the vaccine with no profit during the pandemic and we are supplying the vaccine with no profit in low-income countries today. To date, over 3 billion doses have been released for supply to more than 180 countries. AstraZeneca was the first and largest contributor in 2020 and 2021 to COVAX, with over 470 million doses. Doses that couldn’t have been released without the partnership with ProPharma. In our collaboration an estimated 500 million doses underwent thorough quality assessment to provide a vaccine made for the world.
Pythia Segers - Astra Zeneca
News & Insights

May 29, 2023
Key Challenges of Specialty Pharma Drug Development Project Management
Specialty pharma companies are focused on developing drugs for niche markets, such as rare diseases, cancer, and other complex conditions. These drugs often require significant investment in research...

May 25, 2023
Meet the Expert: Collin Freeman
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...

May 17, 2023
ProPharma Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology
RALEIGH, NC, May 17, 2023, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of Odyssey...

May 9, 2023
ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics
RALEIGH, NC, May 9, 2023, ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and a portfolio company of Odyssey Investment Partners, and H1, a leading healthcare...

May 1, 2023
EY Announces Michael Stomberg as an Entrepreneur Of The Year® 2023 Midwest Award Finalist
Entrepreneur Of The Year celebrates ambitious entrepreneurs who are building bolder futures RALEIGH, NC, May 1, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

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...

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...

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...

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...
News & Insights

May 17, 2023
ProPharma Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology
RALEIGH, NC, May 17, 2023, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of Odyssey...

May 09, 2023
ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics
RALEIGH, NC, May 9, 2023, ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and a portfolio company of Odyssey Investment Partners, and H1, a leading healthcare...

May 01, 2023
EY Announces Michael Stomberg as an Entrepreneur Of The Year® 2023 Midwest Award Finalist
Entrepreneur Of The Year celebrates ambitious entrepreneurs who are building bolder futures RALEIGH, NC, May 1, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

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...

May 29, 2023 7:00:00 AM
Key Challenges of Specialty Pharma Drug Development Project Management
Specialty pharma companies are focused on developing drugs for niche markets, such as rare diseases, cancer, and other complex conditions. These drugs often require significant investment in research...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

May 29, 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...

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...

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...

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...

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...

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...

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...

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...

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...