PSMF is a legal requirement for medical products that are authorized by the European Union. It consists of a detailed description relating to the entire pharmacovigilance system for the organization. It also documents the performance and compliance of the requirements that are described by the Good Pharmacovigilance practices. The content and structure relating to the PSMF are defined in the GVP Module II. It reflects the collection, assessment, handling, storage, and reporting of EU-authorized medicine products. We at Vizen life sciences follow the GVP Module II’s recommendations for the modular-based PSMF. Experts at Vizen leverage their pharmacovigilance expertise to understand the complexity of the PSMF and follow the regulatory guidelines on Good Pharmacovigilance Practice (GVP) that are specific to each PV system. We provide our clients with the review, author, or support in preparing a PSMF in regard to product application or authorization in the EU. In case our client already has PSMF in place, we will provide them with all the support needed including updates and reviews. We work with established documentation systems to create and maintain a PSMF that comprehensively and accurately describes the PV system of your organization in line with the legislative format. A comprehensive PSMF is highly significant as it is a document that is shared with EU regulatory inspectors and provides insights into your organization’s PV system.