Enabling Technology

Introducing Prodigy®: a purpose-built suite of technology-driven solutions that de-risk decision making
& drive value for our partners & sponsors

 

The World's Largest RCO

Leading with strategy, our RCO model offers custom solutions that deliver results. Our fit-for purpose global services span across the full product lifecycle.

 

MedTech solutions

From concept to market, our experts provide custom-tailored medical device & diagnostic solutions to help meet your goals with proven results.

 

Oncology CRO services

Our full-service capabilities ensure the development and execution of a meticulously
designed drug development strategy for your Oncology clinical research project.

 

Strategic Global Partners

Our deep domain expertise spans across the full product lifecycle. with a team of locally-based experts who bring a comprehensive portfolio of services to help solve complex challenges in a dynamic environment.

 

RCO

MedTech

Oncology CRO Services

Global Solutions

Enabling Technology

Introducing Prodigy®: a purpose-built suite of technology-driven solutions that de-risk decision making
& drive value for our partners & sponsors

 

Prodigy: Enabling Technology

RCO

MedTech

Oncology CRO Services

Global Solutions

The World's Largest RCO

Leading with strategy, our RCO model offers custom solutions that deliver results. Our fit-for purpose global services span across the full product lifecycle.

 

Prodigy: Enabling Technology

RCO

MedTech

Oncology CRO Services

Global Solutions

MedTech solutions

From concept to market, our experts provide custom-tailored medical device & diagnostic solutions to help meet your goals with proven results.

 

Prodigy: Enabling Technology

RCO

MedTech

Oncology CRO Services

Global Solutions

Oncology CRO services

Our full-service capabilities ensure the development and execution of a meticulously
designed drug development strategy for your Oncology clinical research project.

 

Prodigy: Enabling Technology

RCO

MedTech

Oncology CRO Services

Global Solutions

Strategic Global Partners

Our deep domain expertise spans across the full product lifecycle. with a team of locally-based experts who bring a comprehensive portfolio of services to help solve complex challenges in a dynamic environment.

 

Prodigy: Enabling Technology

RCO

MedTech

Oncology CRO Services

Global Solutions

ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies

We're pleased to announce that ProPharma has secured its position on the Inc. 5000 List of America's Fastest-Growing Companies for 2023, ranking at 1,678.

Inspiring the Future of Life Sciences to Deliver a Better Tomorrow

Aligning with World Health Day, ProPharma has released a short documentary video demonstrating the value of our unique RCO model which strives to improve global health outcomes.

Watch the Video   →

Watch ProPharma's Global Health Campaign Segment (7:30)

ProPharma proudly introduces something new: the RCO.

The traditional CRO model wasn’t built to handle today’s needs. As the first ever Research Consulting Organization (RCO), we lead with strategy; this enables customized design and delivery of consulting solutions that are equipped to successfully navigate the increasingly complex global Regulatory environment.

Our scalable nature and agility allows each part of our business to invest, innovate, and continuously improve to provide the right solutions for our clients.

- Michael Stomberg, Chief Executive Officer

Michael Stomberg's Signature

BETTER SOLUTIONS. INNOVATIVE PARTNERS.

Welcome to the future of research consulting.

We revolutionized the traditional model, creating an entirely new system that redefines what’s possible for you and your organization. Meet the Research Consulting Organization (RCO)

Custom Solutions for Complex Needs

Click on a segment to learn more about our services
Click to learn more about regulatory sciences services
Click to learn more about clinical research solutions
Click to learn more about quality & compliance services
Click to learn more about pharmacovigilance solutions
Click to learn more about medical information services
Click to learn more about r&d technology services

Explore Our Core Services

One size has never fit all. We’re here to offer a custom alternative that fits your unique needs. A+ solutions scaled to your size. Each of our dedicated service lines provides world-class critical consulting services that operate autonomously across regulatory, safety, technology, and operations, but can perform as an integrated whole. 

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regulatory sciences

ProPharma is the world’s leading regulatory sciences consulting firm offering support across the full lifecycle for drugs, biologics, medical devices, and diagnostics. ProPharma offers pre- and post-approval support for FDA, EMA, and other national competent authorities.
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clinical research solutions

ProPharma offers industry leading support through a global team of trusted experts for multi-phase clinical development and study execution focused on drugs, biologics, medical devices, and diagnostics.
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quality & compliance

ProPharma is an industry leader in quality & compliance with decades of experience in pharma consulting and regulation. ProPharma successfully brings products to market through maintenance of quality and compliance standards and records.
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pharmacovigilance solutions

ProPharma is an industry-leading organization comprised of pharmacovigilance experts, offering a full suite of pharmacovigilance solutions to ensure safety and consistency from clinical development through post-approval.
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medical information

ProPharma provides comprehensive medical information services, including fully integrated 24/7/365 contact centers. Our highly qualified medical information specialists utilize market-leading technologies and innovation to help our clients deliver current and accurate information and improve patient health and safety.
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R&D technology

Science and technology have become increasingly intertwined, and unique expertise is required to move your project through the development lifecycle to completion. ProPharma helps life science organizations achieve technology solutions that enable their products to get to market quickly and efficiently.

Empowering our partners to transform scientific breakthroughs to life-changing patient outcomes & therapies.

Our team of experts have decades of experience across a wide variety of therapeutic areas & specialties. We work as an extension of your team, bringing you immediate resources who will align with your needs, processes, and environment.

Therapeutic areas mobile image

We bring the same passion we have for patients and healthcare solutions to our employees.

 

News & Insights

Quality & Compliance GxP Understanding GxP Compliance in Drug and Medical Device Development Lifecycle

February 29, 2024

Understanding GxP Compliance in Drug and Medical Device Development Lifecycle

In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is...

General Regulatory FDA Meetings Regulatory Sciences Formal FDA Meetings for Sponsors or Applications of PDUFA Products

February 26, 2024

Formal FDA Meetings for Sponsors or Applications of PDUFA Products

This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...

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

February 26, 2024

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

This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

January 24, 2024

ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...

Company News Press Releases Innovation and the Black Swan Prodigy Whitepaper

January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

Press Releases ProPharma Unveils Prodigy: Groundbreaking Technology-Enabled Consulting Platform to Revolutionize Life Science Consulting Industry

January 4, 2024

ProPharma Unveils Prodigy: Groundbreaking Technology-Enabled Consulting Platform to Revolutionize Life Science Consulting Industry

Whitepaper published alongside today's announcement details $5M+ investment and up to 50% improvement in speed, quality, and cost with new AI-enhanced solutions. RALEIGH, NC, January 4, 2023 –...

Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Raleigh, NC, October 11, 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 Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

August 15, 2023

ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...

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

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 Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

January 24, 2024

ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...

Company News Press Releases Innovation and the Black Swan Prodigy Whitepaper

January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

Press Releases ProPharma Unveils Prodigy: Groundbreaking Technology-Enabled Consulting Platform to Revolutionize Life Science Consulting Industry

January 4, 2024

ProPharma Unveils Prodigy: Groundbreaking Technology-Enabled Consulting Platform to Revolutionize Life Science Consulting Industry

Whitepaper published alongside today's announcement details $5M+ investment and up to 50% improvement in speed, quality, and cost with new AI-enhanced solutions. RALEIGH, NC, January 4, 2023 –...

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Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Raleigh, NC, October 11, 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 Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

August 15, 2023

ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...

Previous Award Arrow Next Award Arrow
Quality & Compliance GxP Understanding GxP Compliance in Drug and Medical Device Development Lifecycle

February 29, 2024

Understanding GxP Compliance in Drug and Medical Device Development Lifecycle

In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is...

General Regulatory FDA Meetings Regulatory Sciences Formal FDA Meetings for Sponsors or Applications of PDUFA Products

February 26, 2024

Formal FDA Meetings for Sponsors or Applications of PDUFA Products

This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...

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

February 26, 2024

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

This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...

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

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...

Previous Resource Arrow Next Resource Arrow

Next ProPharma Event

Our team has a consistent pulse on industry changes, the evolving marketplace, and patient needs. We are excited to attend several events in 2023. We look forward to meeting you to share new insights, explore new perspectives, uncover unmet business needs, and continuing professional development.

The Future of Research Consulting is Here

We’ve revolutionized the traditional model and put our clients at the very center.