Global Medical Writing

Medical writing support across the clinical development lifecycle, delivering accurate, submission-ready documentation aligned with global regulatory expectations.

Medical Writing Support Across the Clinical Development Lifecycle

Global development programs require medical writing that is accurate, consistent, and aligned with regulatory expectations. ProPharma provides global medical writing services that support sponsors from early development through submission and post-approval transparency.

Medical writers partner closely with clinical, regulatory, and operational teams to deliver clear, submission-ready documentation that supports efficient execution and inspection readiness.
Medical writers partner closely with clinical, regulatory, and operational teams to deliver clear, submission-ready documentation that supports efficient execution and inspection readiness.

Medical Writing Services

Medical writing support spans a wide range of clinical and regulatory documentation, tailored to program needs and study phase.

  • Clinical study protocols and amendments Investigator’s brochures
  • Informed consent forms
  • Patient narratives and safety documentation
  • Clinical study reports (CSR)
  • Regulatory submission documentation and summaries
  • Responses to health authority questions
  • Peer reviewed journals
  • Clinical trial transparency and disclosure support

Designed for Global Development Programs

Medical writers support programs across North America, Europe, and APAC, addressing regional expectations while maintaining a consistent document strategy across global studies.

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Our Approach to Medical Writing

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Integrated Expertise that Strengthens Delivery

Medical writing teams operate within a broader ecosystem of regulatory, clinical research, pharmacovigilance, and quality expertise. This integration supports scientific accuracy, regulatory alignment, and consistency across deliverables.

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Flexible Delivery Models

Support is available through functional service provision (FSP), hybrid, or fully managed models, allowing sponsors to scale medical writing needs based on timelines, study volume, and program complexity.

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Inspection Ready by Design

Governance, quality review, and version control processes are aligned with sponsor standards and evolving regulatory guidance, supporting confident submissions and health authority inspections.

Medical Writing for Every Phase of Development

Connect with a medical writing expert to discuss global medical writing support for your development program.

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

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Mastering the Pharmacovigilance System Master File (PSMF): A Guide to Inspection...

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Discover how multilingual contact centers enhance accessibility for MAHs, offering scalable solutions from front-desk support to full Medical Information services.

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Discover insights from global experts and understand key industry regulations through our engaging "Meet the Expert" series and comprehensive compliance articles.

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ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.

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.

Case Study Ensure Launch Readiness—Even on the Tightest Timelines

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Case Study How a Novel Real World Evidence Strategy Helped Bring a Class III Device to Market - ProPharma

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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...

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

March 12, 2026

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

Uncover the intricacies of Pharmacovigilance System Master File (PSMF) management and explore proven strategies to ensure inspection readiness, effective MAH oversight, and regulatory compliance...

News & Insights

Mastering the Pharmacovigilance System Master File (PSMF): A Guide to Inspection Readiness

April 2, 2026

Mastering the Pharmacovigilance System Master File (PSMF): A Guide to Inspection...

Explore the purpose of the PSMF, why it is vital during inspections, common regulatory findings, and best practices for keeping it inspection-ready.

A Smarter Front‑Desk Model: Multilingual Contact Center Support for MAHs

March 30, 2026

A Smarter Front‑Desk Model: Multilingual Contact Center Support for MAHs

Discover how multilingual contact centers enhance accessibility for MAHs, offering scalable solutions from front-desk support to full Medical Information services.

The Evolving Role of Functional Service Providers in Clinical Trial Medical Writing: Efficiency, Compliance, and Collaboration

March 23, 2026

The Evolving Role of Functional Service Providers in Clinical Trial Medical Writ...

Discover insights from global experts and understand key industry regulations through our engaging "Meet the Expert" series and comprehensive compliance articles.

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 Welcomes Dan Ryan as President of Clinical Research Solutions

December 4, 2025

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.

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
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...

Case Study How a Novel Real World Evidence Strategy Helped Bring a Class III Device to Market - ProPharma

March 23, 2026

Real World Evidence for Class III Devices: A Smarter Path to PMA

Struggling to generate clinical evidence for Class III devices without costly, multi-year trials? Discover how ProPharma helped an orthopedic device company leverage existing registry data to support...

Flyers CMO Compass & Supply Chain Management - ProPharma

March 16, 2026

CMO Compass & Supply Chain Management

ProPharma provides comprehensive supply chain management and consulting services to support the efficient delivery of clinical trial materials throughout the product lifecycle. Using its CMO Compass®...

Previous Resource Arrow Next Resource Arrow
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...

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

March 12, 2026

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

Uncover the intricacies of Pharmacovigilance System Master File (PSMF) management and explore proven strategies to ensure inspection readiness, effective MAH oversight, and regulatory compliance...

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