We are here to support you in navigating the complexities of PSMF requirements, ensuring your global compliance with pharmacovigilance regulations.

Our services include: –

• Establishment and maintenance of the PSMF
• Setting up PSMF procedures
• Third-party expert PSMF review and gap analysis
• Template transfer of existing PSMF
• Timely revision of PSMF to reflect significant changes in the pharmacovigilance system.

Maintenance of both core EU-PSMF local PSMF(s) and Rest of World (RoW )

• EAEU countries: PSMF
• GCC nations (Arab nations): Country-wise national PSSF/PvSF
• India: Pharmacovigilance System Master File (PvMF)

Our PSMF process is designed to be robust, and risk proportionate. We have established standard operating procedures, defined templates, and checklists to ensure data accuracy and completeness, in full compliance with relevant regulatory requirements.