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 unique Research Consulting Organization (RCO) model allows us to deliver unparalleled, customized service focused on meeting your specific medical writing and clinical trials disclosure needs, whether through standalone project work, full-service trial support, 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.
Explore Medical Writing ServicesQuality 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.
Explore QC Review/EditingClinical 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

Mary Culliton
Senior Vice President, Medical Writing

Janice Worley
Vice President, Medical Writing

Meg Weber
Vice President, Medical Writing

Michael Church
Vice President, Medical Writing

Pinky Sharma
Director, Medical Writing

Carrie Yazell
Director, Medical Writing and Quality Control

Cynthia Fuller
Senior Director, Medical Writing

Complex Needs Require Custom Solutions
ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.
News & Insights

September 27, 2023
The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

September 25, 2023
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September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

September 13, 2023
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August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

May 3, 2022
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

April 21, 2022
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

June 10, 2022
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August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...
News & Insights

September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

April 21, 2022
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

Sep 27, 2023 11:57:42 AM
The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

Sep 25, 2023 4:59:00 PM
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

October 14, 2021
Accelerate European Market Access with Compliant and Comprehensive MAA Submission
Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Placing a medicinal product in the European market requires a license for...

March 18, 2022
Outsourcing QA - Reduce Time and Expense While Meeting Critical Requirements
There is a tendency for VPCs to rely solely on the QC/QA units within their outsourced CMO to perform quality functions. However, the sponsor organization has the ultimate responsibility for product...

October 14, 2021
Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area
Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA. You’re developing a drug, biologic, or medical device product. There are a lot of...

September 1, 2022
Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability
Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response to customer needs. The expectation for higher...

October 14, 2021
Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence
Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. When considering the acquisition of a new company or product, it...

October 14, 2021
Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons
Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...

September 27, 2023
How a Two-Part NDA Regulatory Strategy Resulted in Submission Success
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October 4, 2021
How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach
A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...

October 14, 2021
Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline
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October 4, 2021
Increased Visibility for Senior Management with Custom PMO Design, Implementation
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October 14, 2021
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October 14, 2021
MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction
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September 27, 2023
Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life
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May 19, 2022
Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective
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March 25, 2022
Insider Talks - To Decentralize or Not to Decentralize … That is the Question
Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...

October 14, 2021
Secure Timely Product Launch by Ensuring GDP Compliance Across Europe
Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...

October 14, 2021
Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors
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October 14, 2021
Understanding Clinical Trial Requirements for Medical Device Label Extensions
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September 27, 2023
What You Need to Know About Regulatory Programs for Expedited Approval
Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

October 17, 2021
Outsourcing of Medical Information Content Creation: Experience of 100 Clients
The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

October 4, 2021
Outsourcing Medical Information Services: When to Consider a Dedicated Resource
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May 3, 2023
Improve Quality & Consistency by Leveraging AI for Trial Master File Classification
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