Regulatory Affairs

psn offers a wide range of services in connection with registration of human and veterinary pharmaceuticals, medical devices and biotech products from a full registration package or customized deliverable to translation of a simple text into local languages.

Local presence and experience give psn a clear advantage in assisting its clients with their regulatory needs. Submission activities to Regulatory Authorities (FDA, EMA, Local RAs) and Independent Ethics Committees are completed quickly and efficiently.

More specifically psn offers services within the following areas:

• Development of complete registration applications
• Submission of clinical trial protocols for regulatory authorities/independent ethics committees approval and follow-up
• Modifications, amendments and updating of existing registration files
• CTD for marketing authorization applications
• Production of expert reports within the areas of pharmacy, chemistry, toxicology and clinical data
• Translation of technical text and conduct of literature search
• Production or evaluation of patient information sheets, package labels and summary of product characteristics
• Special assignments