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Expert Regulatory Affairs and FDA Consulting

Our aim is to help your business succeed by working to streamline the pharma regulatory process. ProPharma Group’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 regulatory and business objectives. We develop detailed regulatory affairs strategies for your product, providing a clear path forward through all the critical milestones to achieve a successful outcome. We can also help with your 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.

ProPharma Group continues to build upon our strong foundation of regulatory science with acquisitions that further globalize and deepen our service capabilities. Our integrated team of pharmaceutical regulation specialists has grown through uniting leading regulatory affairs companies such as the former Xendo Life Sciences and Sofus Regulatory Affairs, as well as The Weinberg Group and Southwood Research.

Our veteran regulatory affairs team has over 30 years of experience using scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes with regulatory agencies in the US and Europe. Explore all the ways that ProPharma Group can support your pharmaceutical regulatory affair needs and product pipeline throughout the entire product lifecycle or speak with one of our regulatory consulting experts.

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FDA Consultant Services: Drug Development

From developing and executing your regulatory strategy to obtaining NDA approval, our FDA consultants and regulatory affairs services, combined with our scientific knowledge, experience, and history of working with the FDA, enables us to advance your product quickly and successfully.

US & EU: Medical Device Development

From concept development through FDA approval and the Agency’s post-marketing requirements, our team of regulatory affairs specialists are highly qualified to assist you in all aspects of device regulation throughout the product lifecycle.

EMA/National Agencies Services: Pre-Authorization

Interacting with the European Medicines Agency (EMA) and obtaining the Agency’s approval can seem like a daunting task; our regulatory affairs consultants are here to help you every step of the way.

EMA/National Agencies Services: Regulatory Operations

After your data has been gathered and your submission has been compiled, if it is not submitted appropriately, all of your hard work could fall short and fail. Our regulatory affairs consultants assist with all EMA communication and interaction to achieve successful outcomes

EMA/National Agencies Services: Post-Authorization

We understand your work does not end after EMA approval has been obtained, so neither does ours. Our regulatory affairs expertise and experience extend well into the post-authorization phase to continue and ensure all EMA requirements are completed appropriately.

The ProPharma Group Advantage

Drugs, Biologics, and Medical Devices

Our regulatory affairs experts and FDA consultants specialize in all facets of pharmaceutical and medical device development and regulation

FDA and EMA Expertise

Using our novel approach, which combines deep scientific knowledge and extensive regulatory experience, our pharmaceutical regulation experts help clients achieve successful outcomes with regulators, across continents, within the FDA and EMA

Full Lifecycle Support

From early-stage development through the approval and commercialization of your product, our FDA compliance consultants can assist with all your regulatory needs across the entire product lifecycle

A Global Team of Trusted Regulatory Affairs Experts

Are you in the process of developing an FDA or EMA-regulated product? Our experienced team of FDA regulatory specialists can help you achieve successful regulatory outcomes in the most expeditious way possible and help you realize the value of those outcomes sooner.

Don’t leave your pharmaceutical development strategy to chance. Call or fill out a contact form to speak with a ProPharma Group regulatory affairs consultant today!

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Need Help Navigating the Dynamic Regulatory Market to Bring Your Product Concept to Market?

Contact us to discover how 37+ years of regulatory experience using a strategic and scientific approach can deliver successful and expeditious outcomes.

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