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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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regulatory sciences
clinical research solutions
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R&D technology
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.
News & Insights
September 29, 2023
Navigating FDA User Fee Updates for Fiscal Year 2023
As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...
September 27, 2023
The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...
September 25, 2023
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...
News & Insights
September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
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.