Regulatory Services

Regulatory Services Supporting Successful Outcomes End-To-End

We help our clients achieve positive pharmaceutical regulatory outcomes by using a modern, scientific approach as the driver of success. As the world’s leading provider of regulatory consulting services, we support our clients from pre- through post-approval for both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and similar Organization in geographical regions. MENA-Middle East and North Africa. APAC – Asia Pacific, EMEA – Europe, Middle East and Africa, LAD – Latin America Division, NA – North America, WANA (West Asia and North Africa)

Our aim is to help your business succeed by working to streamline the pharma regulatory process. PSC’s experienced regulatory consulting and 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 each 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.

PSC continues to build upon our strong team of regulatory science in various countries ,that further globalize and deepen our service capabilities. Our integrated team of pharmaceutical regulation specialists has grown through uniting leading local regulatory affairs companies

Our regulatory affairs team has over 10 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 PSC can support your pharmaceutical regulatory affair needs and product pipeline throughout the entire product lifecycle or speak with one of our regulatory consulting experts.