Our pharmacovigilance experts produce compliant PSMFs

A pharmacovigilance (PV) system covering all PV activities is required of all marketing authorization holders. This system must include the activities of collection and processing of safety information, reporting to regulatory authorities, signal detection, and risk minimization, and must clearly describe the organization of the roles and responsibilities involved. A clear description of these PV activities and processes is required in the standard operating procedure (SOP) documents that are included in the PV Quality Management System (QMS).

 A Pharmacovigilance System Master File (PSMF), which describes the company’s PV system and QMS, is required in the European Union (EU)/European Economic Area (EEA). The PSMF describes all PV activities and the stakeholders involved, and is continuously updated. Several other countries also require a PSMF or a similar document, and many have country-specific requirements for what this document contains.

Med Communications’ PV experts have the tools, templates, and accelerators to quickly and efficiently help our clients establish a complete and compliant PSMF. We work closely with our clients to collect the required information, write the main document and annexes, and maintain the PSMF over time within defined review cycles.

Contact us to discuss how we help you ensure create and maintain PSMFs: 877-477-0977 or https://medcommunications.com/contact-us/.