Improving Patient
Health & Safety

Overcoming Challenges. Advancing Therapies.

Trusted Partners.
Proven Results.

Comprehensive Drug Development

Simplifying Complex Challenges Across the Product Lifecycle


For over 25 years, ProPharma has partnered with biotech, pharmaceutical, and medical device organizations to bring groundbreaking therapies to market. Offering a fully customizable, end-to-end suite of services, we empower our clients to overcome regulatory complexities and deliver life-changing therapies to patients worldwide.

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Expert Services and Solutions Throughout the Full Product Lifecycle

We provide specialized consulting services designed to support pharmaceutical, biotechnology, and medical device companies from development to commercialization. Our integrated solutions span regulatory sciences, clinical research, compliance, pharmacovigilance, and medical information - ensuring compliance, efficiency, and success at every stage

Empowering our partners to turn scientific breakthroughs into life-changing therapies

Our team of experts have decades of experience across a wide variety of therapeutic areas & specialties. We work as an extension of your team, bringing you immediate resources who will align with your needs and processes.

 

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Our commitment to patient health and safety is matched by our dedication to fostering a thriving, supportive environment for our team.

 

News & Insights

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

July 28, 2025

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

July 25, 2025

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...

Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).

FDA Publishes over 200 Complete Response Letters (CRLs)

July 24, 2025

FDA Publishes over 200 Complete Response Letters (CRLs)

FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.

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 Drafts to First Patient in Record Time - ProPharma

July 8, 2025

From Drafts to First Patient in Record Time

Launching a global clinical study from draft documents, the team achieved US first patient in in 3.5 months and met ambitious global submission timelines. Strong collaboration, proactive planning,...

Whitepapers FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submission

June 23, 2025

FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submiss...

A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory...

Case Study Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina - ProPharma

June 18, 2025

Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina

Acting as Marketing Authorization Holder in Bosnia and Herzegovina, Clinres—a ProPharma company—helped a global pharma client overcome regulatory delays, misaligned planning, and seasonal launch...

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...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

News & Insights

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

July 28, 2025

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

July 25, 2025

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...

Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).

FDA Publishes over 200 Complete Response Letters (CRLs)

July 24, 2025

FDA Publishes over 200 Complete Response Letters (CRLs)

FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.

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...

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 Drafts to First Patient in Record Time - ProPharma

July 8, 2025

From Drafts to First Patient in Record Time

Launching a global clinical study from draft documents, the team achieved US first patient in in 3.5 months and met ambitious global submission timelines. Strong collaboration, proactive planning,...

Whitepapers FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submission

June 23, 2025

FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submiss...

A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory...

Case Study Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina - ProPharma

June 18, 2025

Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina

Acting as Marketing Authorization Holder in Bosnia and Herzegovina, Clinres—a ProPharma company—helped a global pharma client overcome regulatory delays, misaligned planning, and seasonal launch...

Previous Resource Arrow Next Resource Arrow
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...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

Previous Webinar Arrow Next Webinar Arrow

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