Custom Solutions

ProPharma partners with its clients by providing targeted subject matter experts, world-class strategists, and dedicated program managers to co-create optimal solutions.

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. Fueled by deep domain expertise, we provide end-to-end support across the full product lifecycle.  

Domain Expertise

Women collaborating and looking at blueprints

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

Professional meeting at conference-desk with notebooks and tablets.

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

"We have had the pleasure of working with ProPharma on a global scale for several years assisting us with Medical Information Call Center and writing workflows. Their ability to adapt based on the client’s needs is very commendable. Also, we are fortunate to work with a very talented team of professionals who are always eager to work with us and deliver quality service to our customers."

Anonymous

News & Insights

Understanding For-Cause Audits: A GMP Case Study

May 11, 2026

Understanding For-Cause Audits: A GMP Case Study

Explore the critical role of for-cause audits in GMP environments, uncovering how minor discrepancies can reveal systemic risks and enhance quality oversight.qua

IND Readiness Isn't a Checkbox Exercise, It's a Regulatory Risk Management Strategy

May 5, 2026

IND Readiness Isn't a Checkbox Exercise, It's a Regulatory Risk Management Strat...

Preparing for an IND submission? Discover 12 critical questions sponsors should answer to reduce FDA risk, avoid delays, and strengthen submission readiness.

Cyberattacks in MedTech: Lessons from Stryker, Intuitive, & FDA's Cybersecurity Expectations

April 30, 2026

Cyberattacks in MedTech: Lessons from Stryker, Intuitive, & FDA's Cybersecurity ...

Recent cyberattacks on MedTech leaders highlight growing regulatory and patient safety risks. Explore key lessons and how FDA cybersecurity guidance is shaping compliance and resilience.

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets

January 27, 2026

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...

ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.

ProPharma Expands Operations with New Office in Hyderabad

December 11, 2025

ProPharma Expands Operations with New Office in Hyderabad

ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Whitepapers IND Readiness Checklist: Assess Your FDA Submission Risk

May 4, 2026

IND Readiness Diagnostic: 12 Questions Sponsors Should Answer Before Submitting

A Practical Framework to Assess IND Readiness Before Filing Identify gaps early. Reduce FDA risk. Strengthen your submission strategy. Preparing for an Investigational New Drug (IND) submission...

Case Study Reducing Patient Burden While Maintaining High-Frequency  Monitoring in a Hemophilia Gene  Therapy Trial

April 20, 2026

Reducing Patient Burden While Maintaining High-Frequency Monitoring in a Hemoph...

Balancing rigorous clinical oversight with patient accessibility is critical in complex gene therapy trials. Intensive early-phase monitoring and complex protocols can place significant burden on...

Case Study Ensure Launch Readiness—Even on the Tightest Timelines

March 30, 2026

Ensure Launch Readiness, Even on the Tightest Timelines

Expediting Promotional Review to Deliver 60+ Materials in Just 4 Weeks When timelines are compressed and stakes are high, promotional review processes can quickly become a bottleneck. This case study...

Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

June 2, 2026

Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

A compliant and efficient EU–UK GMP–GDP supply chain requires a clear understanding of roles, responsibilities, and operational integration across importation, certification, and distribution...

Clinical Promise to Commercial Reality: The Path to Cell & Gene Therapy Market

April 23, 2026

Clinical Promise to Commercial Reality: The Path to Cell & Gene Therapy Market

As cell and gene therapies transition from clinical development to commercialization, organizations face evolving regulatory expectations, expanded CMC requirements, and increased MAH...

EMA Policy 0070: Advanced Strategies for Compliance, Anonymization, and CCI Justification

April 9, 2026

EMA Policy 0070: Advanced Strategies for Compliance, Anonymization, and CCI Justification

As European Medicines Agency Policy 0070 enters its expanded Step 2 phase, sponsors face increased document volumes, heightened transparency obligations, and greater scrutiny of anonymization and CCI...

News & Insights

Understanding For-Cause Audits: A GMP Case Study

May 11, 2026

Understanding For-Cause Audits: A GMP Case Study

Explore the critical role of for-cause audits in GMP environments, uncovering how minor discrepancies can reveal systemic risks and enhance quality oversight.qua

IND Readiness Isn't a Checkbox Exercise, It's a Regulatory Risk Management Strategy

May 5, 2026

IND Readiness Isn't a Checkbox Exercise, It's a Regulatory Risk Management Strat...

Preparing for an IND submission? Discover 12 critical questions sponsors should answer to reduce FDA risk, avoid delays, and strengthen submission readiness.

Cyberattacks in MedTech: Lessons from Stryker, Intuitive, & FDA's Cybersecurity Expectations

April 30, 2026

Cyberattacks in MedTech: Lessons from Stryker, Intuitive, & FDA's Cybersecurity ...

Recent cyberattacks on MedTech leaders highlight growing regulatory and patient safety risks. Explore key lessons and how FDA cybersecurity guidance is shaping compliance and resilience.

Previous Post Arrow Next Post Arrow
ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets

January 27, 2026

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...

ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.

ProPharma Expands Operations with New Office in Hyderabad

December 11, 2025

ProPharma Expands Operations with New Office in Hyderabad

ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Whitepapers IND Readiness Checklist: Assess Your FDA Submission Risk

May 4, 2026

IND Readiness Diagnostic: 12 Questions Sponsors Should Answer Before Submitting

A Practical Framework to Assess IND Readiness Before Filing Identify gaps early. Reduce FDA risk. Strengthen your submission strategy. Preparing for an Investigational New Drug (IND) submission...

Case Study Reducing Patient Burden While Maintaining High-Frequency  Monitoring in a Hemophilia Gene  Therapy Trial

April 20, 2026

Reducing Patient Burden While Maintaining High-Frequency Monitoring in a Hemoph...

Balancing rigorous clinical oversight with patient accessibility is critical in complex gene therapy trials. Intensive early-phase monitoring and complex protocols can place significant burden on...

Case Study Ensure Launch Readiness—Even on the Tightest Timelines

March 30, 2026

Ensure Launch Readiness, Even on the Tightest Timelines

Expediting Promotional Review to Deliver 60+ Materials in Just 4 Weeks When timelines are compressed and stakes are high, promotional review processes can quickly become a bottleneck. This case study...

Previous Resource Arrow Next Resource Arrow
Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

June 2, 2026

Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

A compliant and efficient EU–UK GMP–GDP supply chain requires a clear understanding of roles, responsibilities, and operational integration across importation, certification, and distribution...

Clinical Promise to Commercial Reality: The Path to Cell & Gene Therapy Market

April 23, 2026

Clinical Promise to Commercial Reality: The Path to Cell & Gene Therapy Market

As cell and gene therapies transition from clinical development to commercialization, organizations face evolving regulatory expectations, expanded CMC requirements, and increased MAH...

EMA Policy 0070: Advanced Strategies for Compliance, Anonymization, and CCI Justification

April 9, 2026

EMA Policy 0070: Advanced Strategies for Compliance, Anonymization, and CCI Justification

As European Medicines Agency Policy 0070 enters its expanded Step 2 phase, sponsors face increased document volumes, heightened transparency obligations, and greater scrutiny of anonymization and CCI...

Previous Webinar Arrow Next Webinar Arrow