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

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FDA Adds Bemotrizinol to OTC Sunscreen Monograph: What the New GRASE Determination Means for Manufacturers

June 10, 2026

FDA Adds Bemotrizinol to OTC Sunscreen Monograph: What the New GRASE Determinati...

Learn how bemotrizinol achieved GRASE status and what FDA's final order adding the ingredient to the OTC sunscreen monograph means for manufacturers and product development.

Modernizing Case Management for Global Compliance

June 8, 2026

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Discover how E2B (R3) is modernizing pharmacovigilance case management, improving compliance, and streamlining adverse event reporting across global regulatory authorities.

Accelerating European Market Entry: The Strategic Advantage of Using FDA Approval in the UK’s IRP

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ProPharma Appoints Adrian Pencak as Chief Commercial Officer

May 27, 2026

ProPharma Appoints Adrian Pencak as Chief Commercial Officer

ProPharma announces Adrian Pencak as Chief Commercial Officer, bringing 25 years of leadership experience to enhance global commercial capabilities and client partnerships.

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

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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

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

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.

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Case Study Keeping Research Moving Under Pressure: Delivering Data Integrity at Speed

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May 20, 2026

From Clinical Hold to Approval: Overcoming CMC Challenges to Achieve BLA Approva...

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