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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.Explore Regulatory Sciences
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.Explore Clinical Research Solutions
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.Explore R&D Technology
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.Explore Quality & Compliance
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.Explore Pharmacovigilance Solutions
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.Explore Medical Information
Explore our Services. Discover Solutions.
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clinical research solutions
quality & compliance
As the world’s largest Research Consulting Organization, ProPharma provides world class critical consulting services across our services, including regulatory, safety, technology, and operations. With the ability to operate autonomously or as an integrated whole, ProPharma is well positioned to enable each function to invest, innovate and continuously drive improvement to provide the right solutions to our global clients. Delivering bespoke solutions that optimize results through a world class roster of subject matter experts, ProPharma’s team possesses deep domain expertise, which enables the customized design and delivery of consulting solutions to both existing and prospective clients.
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.
“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
News & Insights
January 24, 2024
ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology
RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
January 4, 2024
Innovation and the Black Swan Prodigy Whitepaper
Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...
January 4, 2024
ProPharma Unveils Prodigy: Groundbreaking Technology-Enabled Consulting Platform to Revolutionize Life Science Consulting Industry
Whitepaper published alongside today's announcement details $5M+ investment and up to 50% improvement in speed, quality, and cost with new AI-enhanced solutions. RALEIGH, NC, January 4, 2023 –...
Innovation is Our Foundation
Our industry is in constant flux. If you don’t evolve, you’ll be left behind. Our teams combine agility with deep expertise to innovate across the full development pipeline. We’ve invented a process that suits today’s needs.