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
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.
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.
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.
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.
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.
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...
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...
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...
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...
News & Insights