We work with selected documentation systems to create and support a PSMF that accurately and exhaustively expresses your company’s PV system. A comprehensive PSMF is essential as it is a document shared with EU regulatory inspectors. The Pharmacovigilance System is designed to outline the pharmacovigilance (PV) system of the Marketing Authorization Holder (MAH). The PSMF is part of the registration dossier and should be ready within the required timelines for the Marketing Authorization Application (MAA). Our experts in Atop Pharma Solutions understand the complexness of the PSMF and follow the regulatory guidelines on Good Pharmacovigilance Practice (GVP). We guarantee that you meet all requirements in developing and maintaining your RMP. We help you set up your RMP to identify the risks of a medicinal product efficiently; it helps save your valuable time when interacting with the regulatory authorities.