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

Operational Excellence in Global Clinical Research: Why Culture Drives Performance

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Operational Excellence in Global Clinical Research: Why Culture Drives Performan...

Discover why operational excellence in global clinical research hinges on culture, not just metrics. Learn how leadership, trust, and collaboration drive consistent quality outcomes.

Skinny Labels Under the Microscope: What Hikma v. Amarin Means for Drug Developers

March 17, 2026

Skinny Labels Under the Microscope: What Hikma v. Amarin Means for Drug Develope...

The Supreme Court's review of Hikma v. Amarin could reshape the legal and regulatory landscape for skinny labels and Section viii carve-outs.

Benefits of Site Support

March 16, 2026

Benefits of Site Support

Enhance clinical trial performance with Site Support, offering scalable, specialized assistance to improve recruitment, retention, data quality, and reduce administrative burden for research sites.

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.

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®...

Case Study Restoring Inspection Readiness and Building a Long-Term Pharmacovigilance Partnership - ProPharma

March 13, 2026

Restoring Inspection Readiness and Building a Long-Term Pharmacovigilance Partne...

A mid-sized biotechnology company operating in the EU faced critical pharmacovigilance (PV) compliance findings following an inspection by the European Medicines Agency and Medicines and Healthcare...

Case Study Setting up a Global PV System - ProPharma

February 5, 2026

Setting up a Global PV System

A company needed to rapidly establish a fully compliant global pharmacovigilance (PV) system, including UK/EU QPPV coverage, to meet regulatory requirements by a fixed deadline. With safety data and...

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...

News & Insights

Operational Excellence in Global Clinical Research: Why Culture Drives Performance

March 19, 2026

Operational Excellence in Global Clinical Research: Why Culture Drives Performan...

Discover why operational excellence in global clinical research hinges on culture, not just metrics. Learn how leadership, trust, and collaboration drive consistent quality outcomes.

Skinny Labels Under the Microscope: What Hikma v. Amarin Means for Drug Developers

March 17, 2026

Skinny Labels Under the Microscope: What Hikma v. Amarin Means for Drug Develope...

The Supreme Court's review of Hikma v. Amarin could reshape the legal and regulatory landscape for skinny labels and Section viii carve-outs.

Benefits of Site Support

March 16, 2026

Benefits of Site Support

Enhance clinical trial performance with Site Support, offering scalable, specialized assistance to improve recruitment, retention, data quality, and reduce administrative burden for research sites.

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
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®...

Case Study Restoring Inspection Readiness and Building a Long-Term Pharmacovigilance Partnership - ProPharma

March 13, 2026

Restoring Inspection Readiness and Building a Long-Term Pharmacovigilance Partne...

A mid-sized biotechnology company operating in the EU faced critical pharmacovigilance (PV) compliance findings following an inspection by the European Medicines Agency and Medicines and Healthcare...

Case Study Setting up a Global PV System - ProPharma

February 5, 2026

Setting up a Global PV System

A company needed to rapidly establish a fully compliant global pharmacovigilance (PV) system, including UK/EU QPPV coverage, to meet regulatory requirements by a fixed deadline. With safety data and...

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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