global medical writing & transparency

Your strategic partner for the preparation of regulatory documents.

Colorized half circle.
Confident, smiling man standing with arms crossed

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

Gradient Image

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

Medical Information in the Netherlands: Safeguarding Compliance and Patient Confidence

October 2, 2025

Medical Information in the Netherlands: Safeguarding Compliance and Patient Conf...

Discover how ProPharma's medical information services in the Netherlands ensure patient safety, regulatory compliance, and data privacy with expert support.

Tips for Preparing Successful FDA 510(k) Submissions

September 30, 2025

Tips for Preparing Successful FDA 510(k) Submissions

Discover essential tips for preparing a successful FDA 510(k) submission. Learn common pitfalls to avoid, align with FDA expectations, and streamline your path to clearance.

FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2025

September 26, 2025

FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2...

Insights from FDA’s latest round of compliance letters which indicates a major shift in ad promo oversight revealing new compliance risks for Sponsors.

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 Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

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 Critical Database Lock Milestone Achieved Through Rapid FSP Support for BioXcel Therapeutics, Inc. - ProPharma

October 6, 2025

Critical Database Lock Milestone Achieved Through Rapid FSP Support for BioXcel ...

When BioXcel Therapeutics’ pivotal Phase 3 study faced a critical slowdown, timelines and regulatory goals were at risk. With their primary CRO unable to meet growing demands, ProPharma stepped in —...

Whitepapers Your Complete FDA 510(k) Premarket Notification Checklist

September 30, 2025

Your Complete FDA 510(k) Premarket Notification Checklist

Step-by-step guide to navigating the FDA 510(k) submission process with confidence Submitting a 510(k) premarket notification is a critical milestone for medical device manufacturers seeking U.S....

Infographic Unannounced FDA Inspections Without Borders - ProPharma

September 19, 2025

Unannounced FDA Inspections Without Borders

Unannounced FDA inspections are no longer limited to the U.S. — they’re expanding globally. Starting in 2025, foreign sites will face the same surprise visits and public scrutiny as U.S. facilities,...

Navigating the New EU HTA Regulation as an MAH: Strategic Insights for Successful JCA Submissions

November 18, 2025

Navigating the New EU HTA Regulation as an MAH: Strategic Insights for Successful JCA Submissions

Explore how the new EU HTA Regulation (EU HTAR) is transforming market access across Europe. Join our expert to learn practical strategies for successful Joint Clinical Assessment (JCA) submissions,...

AI in Medical Information: Who Holds the Responsibility?

October 16, 2025

AI in Medical Information: Who Holds the Responsibility?

In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...

Improving Patient Health and Safety through Pharmacovigilance and Medical Information Synergy

September 25, 2025

Improving Patient Health and Safety through Pharmacovigilance and Medical Information Synergy

Medical Information (MI) and Pharmacovigilance (PV) work together to protect public health by identifying and evaluating emerging safety signals. Watch our in-depth webinar, where our experts explore...

News & Insights

Medical Information in the Netherlands: Safeguarding Compliance and Patient Confidence

October 2, 2025

Medical Information in the Netherlands: Safeguarding Compliance and Patient Conf...

Discover how ProPharma's medical information services in the Netherlands ensure patient safety, regulatory compliance, and data privacy with expert support.

Tips for Preparing Successful FDA 510(k) Submissions

September 30, 2025

Tips for Preparing Successful FDA 510(k) Submissions

Discover essential tips for preparing a successful FDA 510(k) submission. Learn common pitfalls to avoid, align with FDA expectations, and streamline your path to clearance.

FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2025

September 26, 2025

FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2...

Insights from FDA’s latest round of compliance letters which indicates a major shift in ad promo oversight revealing new compliance risks for Sponsors.

Previous Post Arrow Next Post Arrow
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 Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

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 Critical Database Lock Milestone Achieved Through Rapid FSP Support for BioXcel Therapeutics, Inc. - ProPharma

October 6, 2025

Critical Database Lock Milestone Achieved Through Rapid FSP Support for BioXcel ...

When BioXcel Therapeutics’ pivotal Phase 3 study faced a critical slowdown, timelines and regulatory goals were at risk. With their primary CRO unable to meet growing demands, ProPharma stepped in —...

Whitepapers Your Complete FDA 510(k) Premarket Notification Checklist

September 30, 2025

Your Complete FDA 510(k) Premarket Notification Checklist

Step-by-step guide to navigating the FDA 510(k) submission process with confidence Submitting a 510(k) premarket notification is a critical milestone for medical device manufacturers seeking U.S....

Infographic Unannounced FDA Inspections Without Borders - ProPharma

September 19, 2025

Unannounced FDA Inspections Without Borders

Unannounced FDA inspections are no longer limited to the U.S. — they’re expanding globally. Starting in 2025, foreign sites will face the same surprise visits and public scrutiny as U.S. facilities,...

Previous Resource Arrow Next Resource Arrow
Navigating the New EU HTA Regulation as an MAH: Strategic Insights for Successful JCA Submissions

November 18, 2025

Navigating the New EU HTA Regulation as an MAH: Strategic Insights for Successful JCA Submissions

Explore how the new EU HTA Regulation (EU HTAR) is transforming market access across Europe. Join our expert to learn practical strategies for successful Joint Clinical Assessment (JCA) submissions,...

AI in Medical Information: Who Holds the Responsibility?

October 16, 2025

AI in Medical Information: Who Holds the Responsibility?

In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...

Improving Patient Health and Safety through Pharmacovigilance and Medical Information Synergy

September 25, 2025

Improving Patient Health and Safety through Pharmacovigilance and Medical Information Synergy

Medical Information (MI) and Pharmacovigilance (PV) work together to protect public health by identifying and evaluating emerging safety signals. Watch our in-depth webinar, where our experts explore...

Previous Webinar Arrow Next Webinar Arrow