Pharmacovigilance Site Master File (PSMF)

The Pharmacovigilance System Master File (PSMF) is a cornerstone of regulatory compliance, offering a comprehensive overview of a company’s pharmacovigilance system and its role in safeguarding medicinal product safety throughout the lifecycle. An accurate, up-to-date PSMF is essential for fulfilling global regulatory obligations, managing safety risks, and ensuring patient protection.

At Adaptis, we streamline the creation and maintenance of your PSMF through a robust, cross-referenced framework that ensures seamless linkage between key systems, processes, and safety functions. Our approach guarantees complete transparency and traceability—delivering a file that is both inspection-ready and fully aligned with health authority expectations.

Our End-to-End PSMF Services Include:

• Development and Authoring of the PSMF
• Regular Reviews, Revisions, and Updates
• Establishment of PSMF SOPs and Procedures
• Gap Analysis and Compliance Audits
• Central Maintenance of Core PSMF Documents

We employ risk-based methodologies, industry-aligned SOPs, and QA-approved templates to ensure consistency, accuracy, and audit-readiness—making Adaptis your trusted partner for global PSMF management.