global medical writing & transparency

Your strategic partner for the preparation of regulatory documents.

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Navigate the ever-evolving regulatory landscape with a flexible and agile team of trusted experts

Our distinct approach enables us to provide exceptional, tailored support for your medical writing and clinical trial disclosure needs, whether through standalone projects, comprehensive trial assistance, or dedicated FSP resourcing.

Medical Writing and Clinical Trials Disclosure

We are knowledgeable and solutions-oriented subject matter experts with deep domain expertise who focus on every detail to deliver a superior client experience.

 

Medical Writing

ProPharma's medical writers provide strategic, responsive, and flexible medical writing project support. Our team of experts autonomously drive document development, assimilating and summarizing complex scientific data into concise, accurate reports for a wide variety of audiences.

Whether you need project-based support for individual medical writing deliverables or to outsource all medical writing across an entire clinical trial or a complete portfolio of products, our expertise and experience can be leveraged to ensure all your project goals are achieved.

Quality Control Review

Detailed, thorough quality control (QC) reviews are an integral part of the production lifecycle of a document. ProPharma's QC experts review documents across all therapeutic areas to ensure message uniformity, data integrity, and consistency.

Clinical Trials Disclosure Services

ProPharma partners with clients to provide individualized, single-source, scalable solutions within the clinical trials disclosure and transparency landscape.

Thousands of Records Posted, >90% without NIH Comments

Finding experienced resources to register and report your clinical trial, provide document redaction services, or locating the right team for end-to-end management and support of an entire portfolio of studies can be difficult.

Our Clinical Trials Disclosure (CTD) experts are here for you.

Our dedicated team of disclosure experts have successfully registered thousands of studies across multiple registries/therapeutic areas and reviewed thousands of pages for personal and commercially confidential information for redaction.

Let our seasoned project managers and authors navigate you through the ever-evolving clinical trials disclosure landscape. 


Medical Writing & Clinical Trials Disclosure Experts

  • Pinky Sharma Bio Photo

    Pinky Sharma

    Director, Medical Writing

  • Janice Worley Bio Photo

    Janice Worley

    Global Head, FSP Services

  • Meg Weber Bio Photo

    Meg Weber

    Vice President, Medical Writing

  • Carrie Yazell Bio Photo

    Carrie Yazell

    Director, Medical Writing and Quality Control

  • Cynthia Fuller Bio Photo

    Cynthia Fuller

    FSP Medical Writing Division Head

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Meeting Complex Needs with Strategic Support

ProPharma provides adaptable and targeted assistance designed to align with your specific requirements. Our approach ensures effective outcomes tailored to your scope and scale.

News & Insights

Preparing for eCTD 4.0: What FDA Submitters Need to Know

January 29, 2026

Preparing for eCTD 4.0: What FDA Submitters Need to Know

eCTD 4.0 is coming. Learn what’s changing, why early planning matters, and how FDA submitters can prepare for a smooth transition.

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outsourcing, and Quality Assurance

January 26, 2026

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outs...

Discover how pharmaceutical and biotech companies can elevate laboratory compliance in 2026 through GLP, strategic outsourcing, and robust quality assurance.

2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026

January 14, 2026

2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026

Explore 2025's FDA enforcement trends, OPDP changes, and evolving guidance shaping pharma advertising, MLR review, and compliance strategies for 2026.

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.

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 High-Volume Global Pharmacovigilance Onboarding - ProPharma

January 30, 2026

High-Volume Global Pharmacovigilance Onboarding

A global biotechnology sponsor faced a sudden surge in pharmacovigilance demand, with monthly ICSR volumes exceeding 30,000 cases across multiple regions. Limited internal capacity, tight onboarding...

Case Study Stabilizing High-Volume Legal Case Processing Through Structured Governance - ProPharma

January 28, 2026

Stabilizing High-Volume Legal Case Processing Through Structured Governance

ProPharma’s client faced escalating operational risk as high-volume legal case documentation overwhelmed their prior vendor. Thousands of documents, missed regulatory timelines, and a surge of...

Case Study Overcoming Operational Hurdles in a High-Stakes Stroke Trial - ProPharma

December 15, 2025

Overcoming Operational Hurdles in a High-Stakes Stroke Trial

Argenica Therapeutics’ Phase 2 acute ischaemic stroke trial faced the challenges of unpredictable patient presentation, narrow treatment windows, and demanding emergency care environments. This...

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...

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

February 17, 2026

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

With promotional scrutiny increasing around areas such as social media, influencer campaigns, direct-to-consumer (DTC) messaging, and data-driven claims, the session walks through the characteristics...

Scaling High-Quality Medical Information Through Offshoring

February 11, 2026

Scaling High-Quality Medical Information Through Offshoring

Navigate the complexities of offshoring Medical Information and explore proven strategies to ensure consistent quality, regulatory compliance, and seamless global execution. Join us for an...

News & Insights

Preparing for eCTD 4.0: What FDA Submitters Need to Know

January 29, 2026

Preparing for eCTD 4.0: What FDA Submitters Need to Know

eCTD 4.0 is coming. Learn what’s changing, why early planning matters, and how FDA submitters can prepare for a smooth transition.

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outsourcing, and Quality Assurance

January 26, 2026

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outs...

Discover how pharmaceutical and biotech companies can elevate laboratory compliance in 2026 through GLP, strategic outsourcing, and robust quality assurance.

2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026

January 14, 2026

2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026

Explore 2025's FDA enforcement trends, OPDP changes, and evolving guidance shaping pharma advertising, MLR review, and compliance strategies for 2026.

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 High-Volume Global Pharmacovigilance Onboarding - ProPharma

January 30, 2026

High-Volume Global Pharmacovigilance Onboarding

A global biotechnology sponsor faced a sudden surge in pharmacovigilance demand, with monthly ICSR volumes exceeding 30,000 cases across multiple regions. Limited internal capacity, tight onboarding...

Case Study Stabilizing High-Volume Legal Case Processing Through Structured Governance - ProPharma

January 28, 2026

Stabilizing High-Volume Legal Case Processing Through Structured Governance

ProPharma’s client faced escalating operational risk as high-volume legal case documentation overwhelmed their prior vendor. Thousands of documents, missed regulatory timelines, and a surge of...

Case Study Overcoming Operational Hurdles in a High-Stakes Stroke Trial - ProPharma

December 15, 2025

Overcoming Operational Hurdles in a High-Stakes Stroke Trial

Argenica Therapeutics’ Phase 2 acute ischaemic stroke trial faced the challenges of unpredictable patient presentation, narrow treatment windows, and demanding emergency care environments. This...

Previous Resource Arrow Next Resource Arrow
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...

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

February 17, 2026

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

With promotional scrutiny increasing around areas such as social media, influencer campaigns, direct-to-consumer (DTC) messaging, and data-driven claims, the session walks through the characteristics...

Scaling High-Quality Medical Information Through Offshoring

February 11, 2026

Scaling High-Quality Medical Information Through Offshoring

Navigate the complexities of offshoring Medical Information and explore proven strategies to ensure consistent quality, regulatory compliance, and seamless global execution. Join us for an...

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