Expert Regulatory Affairs: FDA and EMA 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, Southwood Research, Diamond Pharma Services, and NDA Partners.
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.