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

Why MI Experts Can Reduce Operational Burden for Pharma Companies

August 28, 2025

Why MI Experts Can Reduce Operational Burden for Pharma Companies

Discover how partnering with MI experts at ProPharma can reduce operational burdens, enhance compliance, and improve efficiency for pharmaceutical companies.

Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member States in CTIS

August 26, 2025

Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member Sta...

Successfully expand clinical trials to additional EU Member States under the CTR framework. Explore strategies for patient recruitment, regulatory compliance, and minimizing CTIS approval delays.

Selecting a PMPV Vendor, Part II: Building on a Strong Foundation

August 25, 2025

Selecting a PMPV Vendor, Part II: Building on a Strong Foundation

Discover the essentials of selecting the right pharmacovigilance vendor for post-marketing safety, ensuring compliance, flexibility, and effective signal detection.

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.

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...

Case Study Simplifying Global MLR Review: Local Expertise at a Global Scale

August 4, 2025

Simplifying Global MLR Review: Local Expertise at a Global Scale

Struggling to streamline MLR review across international markets? Discover how our team helped a leading pharmaceutical company reduce review timelines, ensure regulatory compliance, and eliminate...

Case Study Successfully Executing a Tech Transfer in a Week - ProPharma

July 29, 2025

Successfully Executing a Tech Transfer in a Week

Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...

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,...

Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

News & Insights

Why MI Experts Can Reduce Operational Burden for Pharma Companies

August 28, 2025

Why MI Experts Can Reduce Operational Burden for Pharma Companies

Discover how partnering with MI experts at ProPharma can reduce operational burdens, enhance compliance, and improve efficiency for pharmaceutical companies.

Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member States in CTIS

August 26, 2025

Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member Sta...

Successfully expand clinical trials to additional EU Member States under the CTR framework. Explore strategies for patient recruitment, regulatory compliance, and minimizing CTIS approval delays.

Selecting a PMPV Vendor, Part II: Building on a Strong Foundation

August 25, 2025

Selecting a PMPV Vendor, Part II: Building on a Strong Foundation

Discover the essentials of selecting the right pharmacovigilance vendor for post-marketing safety, ensuring compliance, flexibility, and effective signal detection.

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
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...

Case Study Simplifying Global MLR Review: Local Expertise at a Global Scale

August 4, 2025

Simplifying Global MLR Review: Local Expertise at a Global Scale

Struggling to streamline MLR review across international markets? Discover how our team helped a leading pharmaceutical company reduce review timelines, ensure regulatory compliance, and eliminate...

Case Study Successfully Executing a Tech Transfer in a Week - ProPharma

July 29, 2025

Successfully Executing a Tech Transfer in a Week

Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...

Previous Resource Arrow Next Resource Arrow
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,...

Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Previous Webinar Arrow Next Webinar Arrow