Pharmacovigilance System Master File

Compliant, and inspection-ready PV system file

We provide end-to-end support for the creation, maintenance, and electronic management of Pharmacovigilance System Master Files (PSMF) and country-specific Pharmacovigilance Sub-System Files (PSSF).
Our services ensure full compliance with EU GVP and global pharmacovigilance regulations through structured documentation, controlled updates, and audit-ready systems.

PSMF Development & Maintenance
Preparation, periodic review, and lifecycle management of PSMF in line with EU GVP Module II requirements.
PSMF Summary
Development of a concise, regulator-ready PSMF Summary suitable for inspections and authority submissions.
Electronic PSMF (e-PSMF) Database
Design and implementation of an electronic PSMF repository enabling Marketing Authorisation Holders (MAHs) to maintain, control, and distribute PSMF documentation securely and efficiently.
Country-Specific PSSF (PV Sub-System File)
Creation and maintenance of local PSSF aligned with national regulatory requirements and local PV operations.
Ongoing Maintenance & Change Management
Regular updates to PSMF/PSSF reflecting organizational, system, vendor, procedural, and regulatory changes—ensuring continuous inspection readiness.

A robust, compliant, and inspection-ready PV system file framework that supports regulatory submissions, authority inspections, and global pharmacovigilance operations.

Pharmacovigilance Services

Contact Us

  • B04-332, Business Center 03, RAKEZ Business Zone-FZ,
    Ras Al Khaimah, UAE
  • +971 55 895 5849
  • info@yashfin.net
    info@yashfinpharma.com

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Explore our Service Prospectus for a clear, easy-to-read overview of all services we offer.

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