Our Services

Strategy-Led Solutions on a Global Scale. Fueled by extensive knowledge, ProPharma provides end-to-end support across the full product lifecycle.

Our Services

Strategy-Led Solutions on a Global Scale. Fueled by extensive knowledge, ProPharma provides end-to-end support across the full product lifecycle.

Explore Our Services. Discover Solutions.

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Regulatory Sciences

Regulatory Sciences

ProPharma is the world’s leading regulatory sciences consulting firm offering support across the full life cycle for drugs, biologics, medical devices, and diagnostics. ProPharma offers pre and post approval for FDA, EMA, and national competent authorities.

ProPharma’s aim is to help your business succeed by working to streamline the pharma regulatory process. ProPharma’s experienced regulatory consulting and FDA compliance team commands an unparalleled breadth and depth of knowledge pertaining to the FDA and EMA regulatory frameworks and can work with you to accomplish your business objectives. Our regulatory consultants develop detailed strategies for your product, providing a clear path forward through all the critical milestones to achieve a successful outcome. We also support post-authorization regulatory pharma needs, including the launch of your product, line extensions (LE) and variations, and maintaining your products’ optimal regulatory status throughout its lifecycle.

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Clinical Research Solutions

Clinical Research Solutions

ProPharma offers industry leading support through a global team of trusted experts for multi-phase clinical development and study execution focused on therapies, medical devices, and diagnostics.

Our team of clinical research experts brings breadth and depth of experience across all phases of clinical trials, applying proven techniques to provide innovative solutions. Regardless of where you are in the product lifecycle or what your clinical trial-related needs are, we offer clinical research solutions to efficiently bring your product to market. With decades of industry experience, our team of clinical research experts is current with the latest industry intelligence and ever-evolving regulations, making ProPharma the partner of choice when outsourcing your clinical trials.

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R&D Technology

R&D Technology

Science and technology have become increasingly intertwined, and unique expertise is required to move your project through the development lifecycle to completion. ProPharma helps life science organizations achieve technology solutions that enable their products to get to market quickly and efficiently.

With access to the latest technology and trends, ProPharma’s team of R&D technology consultants takes an integrated approach to determine the right fit-for-purpose technology solutions for our pharmaceutical and biotech clients. We know there is no one-size-fits-all approach when it comes to science and technology, and we don’t treat our projects as if there is.

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Quality & Compliance

Quality & Compliance

ProPharma is an industry leader in quality & compliance with decades of experience in pharma consulting and regulation. ProPharma successfully brings products to market through maintenance of quality and compliance standards and records.

Our team of quality & compliance consultants apply proven and proprietary project management methodologies to help our clients successfully develop and launch products to market. ProPharma offers an expansive suite of consulting services to ensure quality, compliance, efficiency, and safety throughout the full lifecycle of a product. Working as an extension of your team, our consultants support you with the highest quality of services by providing best practices and proven insights on program and process management that are aligned with our mission to improve the health and safety of patients.

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Pharmacovigilance Solutions

Pharmacovigilance Solutions

ProPharma is an industry leading organization comprised of Pharmacovigilance experts, offering a full suite of pharmacovigilance solutions to ensure safety and consistency from clinical development through post-approval.

ProPharma’s team of highly qualified pharmacovigilance experts, combined with integrated technology, ensures your product meets the highest levels of compliance with both regional and global pharmacovigilance regulations. We are well equipped to expand as your business grows, guiding you through every step of the pharmacovigilance process and pivoting to meet your developing needs. ProPharma’s team is prepared to handle large case volumes at a global scale, supporting clients throughout the complete product lifecycle. Our pharmacovigilance services are available on a standalone basis or can be integrated with global Medical Information and Regulatory Sciences.

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Medical Information

Medical Information

ProPharma provides comprehensive medical information services, including fully integrated 24/7/365 contact centers. Our highly qualified medical information specialists utilize market-leading technologies and innovation to help our clients deliver current and accurate information and improve patient health and safety.

With strategically positioned and seamlessly integrated contact centers around the world, we provide customizable medical information services to meet the needs of companies of all sizes. Whether you need adverse event intake and follow-up, medical writing and content management solutions, promotional review, or other extended medical information services, our team of medical information specialists have the knowledge and experience to effectively support your needs.

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Explore our Services. Discover Solutions.

Click on a segment to learn more about our services
Click to learn more about regulatory sciences services
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Discover all ProPharma Services

A flexible approach designed to meet your specific needs. We provide an alternative that aligns with your goals, offering exceptional support at the right scale. Our specialized service lines operate independently across regulatory, safety, technology, and operations while seamlessly working together as a unified team.
Regulatory Science flywheel icon.

regulatory sciences

ProPharma is a leading regulatory sciences consulting firm providing support throughout the entire lifecycle of drugs, biologics, medical devices, and diagnostics. We offer pre- and post-approval guidance for FDA, EMA, and national competent authorities.
Clinical Research Solutions flywheel icon.

clinical research solutions

ProPharma offers industry leading support through a global team of trusted experts for multi-phase clinical development and study execution focused on therapies, medical devices, and diagnostics.
Quality & Compliance flywheel icon.

quality & compliance

ProPharma is an industry leader in quality & compliance with decades of experience in consulting across the pharmaceutical, biotech, medical device and diagnostics space. ProPharma successfully brings products to market through maintenance of quality and compliance standards and records.
Pharmacovigilance flywheel icon.

pharmacovigilance solutions

ProPharma is an industry leading organization comprised of Pharmacovigilance experts, offering a full suite of pharmacovigilance solutions to ensure safety and consistency from clinical development through post-approval.
Medical information flywheel icon.

medical information

ProPharma delivers extensive medical information services, including fully integrated 24/7/365 contact centers. Our experienced medical information specialists leverage advanced technologies to provide accurate, up-to-date information, supporting improved patient health and safety.
Research & Development flywheel icon.

R&D technology

Science and technology have become increasingly intertwined, and unique expertise is required to move your project through the development lifecycle to completion. ProPharma helps life science organizations achieve technology solutions that enable their products to get to market quickly and efficiently.

Trusted Expertise. Proven Results.

As a leading pharmaceutical and MedTech consulting firm, ProPharma delivers critical services across regulatory, safety, technology, and operations. Our teams function independently or as a fully integrated unit, continuously enhancing capabilities to support global clients effectively. With a commitment to excellence, ProPharma provides strategic support designed to optimize outcomes through a highly experienced team of subject matter experts.

Strategy-Led Solutions with Global Scale

Custom solutions across the full product lifecycle that fit your unique needs

Fueled by deep domain expertise, ProPharma advises its clients to enable the co-creation of optimal solutions, build and execute operating models, develop related capabilities, and position its clients for continuous and sustained growth and success. ProPharma embraces partnership to reduce delays and drive consistency with dedicated and experienced strategists and program managers for end-to-end solutioning across the full product lifecycle. 

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Client Feedback

 

“Lyell engaged Pro Pharma as our validation partner as we built and qualified the LyFE Manufacturing Center. Pro Pharma assisted in all phases of the qualification including establishing the facility and equipment qualification program, protocol generation, protocol execution, and writing the final reports. They played a critical role in getting the facility ready on time and on budget to support the Lyell clinical trials.”

David Shank - Lyell Immunopharma, Inc.

Vice President, Manufacturing

"The ProPharma Group has been a valued and trusted partner as our Medical Information third party call center for a number of years. During that time they have exhibited the highest level of quality, compliance, and professionalism. Always keeping the needs of our mutual customers front and center. The team is diverse in their staff and their offered services, which enables us to customize support to business need. We would highly recommend the services of ProPharma without hesitation.”

Laurie Wingett - Bayer, Inc.

Medical Affairs Head, Primary Care (WH/established brands) and Medical Operations

“Working with Pro Pharma has been a pleasure. The auditors are friendly, knowledgeable, and communicative. They have been a great resource to help us complete a wide range of audits and manage our supplier quality.”

Emily King - Azurity Pharmaceuticals

"Working with the whole team at ProPharma Group has been an honor. For several years they have acted on our behalf as a trusted customer facing vendor for medical information inquiries. their subject matter expertise, collaborative nature and high level of professionalism have been a bellwether for us through all stages of marketing and scaling a new drug product. The next time my team is in need of scientific" communication outsourcing, PPG will be my first stop.

Jenny Strauss​ - Biohaven Pharmaceuticals

Manager, Medical Information and Communications

When we partnered with Oxford University to enable global development, manufacturing and distribution of our vaccine, we put broad and equitable access at the heart of our response. The result was a vaccine that was developed in under a year, and we believe we have made a significant impact in terms of global public health. Based on data published in The Lancet and an analysis by Airfinity, our vaccine is estimated to have saved over 6 million lives in the first year of vaccination.

AstraZeneca supplied the vaccine with no profit during the pandemic and we are supplying the vaccine with no profit in low-income countries today. To date, over 3 billion doses have been released for supply to more than 180 countries. AstraZeneca was the first and largest contributor in 2020 and 2021 to COVAX, with over 470 million doses. Doses that couldn’t have been released without the partnership with ProPharma. In our collaboration an estimated 500 million doses underwent thorough quality assessment to provide a vaccine made for the world.

Pythia Segers - Astra Zeneca

News & Insights

Vigilance by Another Name

February 17, 2025

Vigilance by Another Name

Explore the various types of vigilance in healthcare and research, from pharmacovigilance to algorithmovigilance, and learn how regulatory intelligence ensures compliance and safety.

Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance

February 12, 2025

Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance

BIMO Inspection Readiness Audits are crucial for ensuring compliance in clinical and biological research. Learn why staying prepared is essential for maintaining regulatory standards.

Drug Development: The Key to Success from Concept to Commercialization

February 11, 2025

Drug Development: The Key to Success from Concept to Commercialization

Navigate the complex but successful drug development journey from concept to commercialization with expert regulatory consultancy.

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 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 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.

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

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 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.

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
Vigilance by Another Name

February 17, 2025

Vigilance by Another Name

Explore the various types of vigilance in healthcare and research, from pharmacovigilance to algorithmovigilance, and learn how regulatory intelligence ensures compliance and safety.

Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance

February 12, 2025

Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance

BIMO Inspection Readiness Audits are crucial for ensuring compliance in clinical and biological research. Learn why staying prepared is essential for maintaining regulatory standards.

Drug Development: The Key to Success from Concept to Commercialization

February 11, 2025

Drug Development: The Key to Success from Concept to Commercialization

Navigate the complex but successful drug development journey from concept to commercialization with expert regulatory consultancy.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow
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Accessible Expertise

With constant shifts in the industry, staying ahead requires flexibility. Our teams blend agility with extensive knowledge to drive advancements across the full development pipeline, creating approaches that meet today's demands.