The Pharmacovigilance System Master File (PSMF) is a legal requirement in the European Union (EU). A PSMF shall describe the pharmacovigilance (PV) system for one or more medicinal products of a marketing authorization holder (MAH) and support/document its compliance thus managing and improving the PV system.
Risk Management Services
PRA Health Sciences (PRA) experts have significant experience providing end-to-end risk management services. Our integrated global teams identify…
Aggregate Safety Reports
PRA Health Sciences (PRA) is dedicated to ensuring quality Aggregate Safety Reports are delivered to our sponsor and MAH partners. Our experienced…
Pharmacovigilance & Patient Safety
Clinical trial participants help us speed breakthroughs in modern drug development. Our job is to protect them.