Pharmacovigilance system master file

The Pharmacovigilance System Master File (PSMF) is a detailed description of PhV and safety procedures, which a company has to follow when handling a medicinal product.

PSMF allows the authorized pharmacovigilance officers  to make sure that the company PhV system is implemented in line with EEU regulatory requirements.

The structure/content of PSMF is regulated by EEU GVP Rules.

Aston Health offers the services of competent PhV specialists that will help you introduce changes to the structure/content of PSMF following the update of EEU GVP Rules on May 19, 2022.

Aleksandr Ivanov

Aleksandr Ivanov

Head of Strategic Consulting Department

Contact us and we will offer the best solution for your needs