global medical writing & transparency

Your strategic partner for the preparation of regulatory documents.

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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

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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

FDA Launches Crackdown on Deceptive Drug Advertising

September 10, 2025

FDA Launches Crackdown on Deceptive Drug Advertising

FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths

September 10, 2025

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Co...

Discover two distinct paths for creating a global audit strategy in medical device companies, focusing on harmonization and compliance efficiency ahead of FDA's 2026 QMSR changes.

FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?

September 9, 2025

FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?

FDA will now release Complete Response Letters in real time. Learn what this transparency means for drug developers, investors, and the industry.

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.

Guide Your Roadmap to European Drug Approval: The Complete Solution - ProPharma

September 9, 2025

Your Roadmap to European Drug Approval: The Complete Solution

Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...

Whitepapers Agility Meets Expertise: The ProPharma FSP Approach - ProPharma

September 3, 2025

Agility Meets Expertise: The ProPharma FSP Approach

Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...

Case Study From Local Limits to Global Integration: Transforming Medical Information Services in Japan - ProPharma

August 21, 2025

From Local Limits to Global Integration: Transforming Medical Information Servic...

Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...

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...

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

September 17, 2025

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...

News & Insights

FDA Launches Crackdown on Deceptive Drug Advertising

September 10, 2025

FDA Launches Crackdown on Deceptive Drug Advertising

FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths

September 10, 2025

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Co...

Discover two distinct paths for creating a global audit strategy in medical device companies, focusing on harmonization and compliance efficiency ahead of FDA's 2026 QMSR changes.

FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?

September 9, 2025

FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?

FDA will now release Complete Response Letters in real time. Learn what this transparency means for drug developers, investors, and the industry.

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
Guide Your Roadmap to European Drug Approval: The Complete Solution - ProPharma

September 9, 2025

Your Roadmap to European Drug Approval: The Complete Solution

Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...

Whitepapers Agility Meets Expertise: The ProPharma FSP Approach - ProPharma

September 3, 2025

Agility Meets Expertise: The ProPharma FSP Approach

Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...

Case Study From Local Limits to Global Integration: Transforming Medical Information Services in Japan - ProPharma

August 21, 2025

From Local Limits to Global Integration: Transforming Medical Information Servic...

Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...

Previous Resource Arrow Next Resource Arrow
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...

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

September 17, 2025

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...

Previous Webinar Arrow Next Webinar Arrow