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
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Five Metrics That Predict CRO Success (and How to Measure Them)
Discover five key metrics to evaluate CRO success, ensuring timely clinical trials and data integrity while minimizing costs. Learn how to measure them effectively.
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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.
June 18, 2026
ProPharma Welcomes Kevin van Dooren to Strengthen Integrated EU Regulatory and H...
ProPharma welcomes Kevin van Dooren as Vice President, HEOR and Market Access, strengthening integrated EU regulatory, HTA, reimbursement, and market access capabilities for life sciences companies.
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.
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.
June 17, 2026
Meeting Patients Where They Are: Delivering Global Clinical Support for Time-Sen...
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Accelerating Commercial Readiness for a Novel Cell Therapy Program
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Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution
A compliant and efficient EU–UK GMP–GDP supply chain requires a clear understanding of roles, responsibilities, and operational integration across importation, certification, and distribution...
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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...
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EMA Policy 0070: Advanced Strategies for Compliance, Anonymization, and CCI Justification
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News & Insights
June 17, 2026
Meeting Patients Where They Are: Delivering Global Clinical Support for Time-Sen...
Conducting clinical research for rare pediatric populations presents unique operational challenges, particularly when eligible patients may be born anywhere in the world and require immediate...
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...