global medical writing & transparency
Your strategic partner for the preparation of regulatory documents.

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.

Global Medical Writing and Transparency
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
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Pinky Sharma
Director, Medical Writing
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Janice Worley
Global Head, FSP Services
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Meg Weber
Vice President, Medical Writing
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Carrie Yazell
Director, Medical Writing and Quality Control
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Cynthia Fuller
FSP Medical Writing Division Head
Pinky Sharma
Janice Worley
Meg Weber
Carrie Yazell
Cynthia Fuller

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

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.

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.

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...

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.

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.

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.

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 —...
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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....

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,...

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...

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

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 —...

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,...

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...