Pharmacovigilance System Master File (PSMF)

A Pharmacovigilance System Master File (PSMF) is required in many countries to be a Marketing Authorization Holder. The PSMF needs to be available for inspections and/or audits at all times. Required components varies across geographic regions.

The QMS is fundamental to all aspects of pharmacovigilance. In addition to building your QMS, we can provide full Quality Management System reviews. If your organization has recently finished an inspection or audit, our QMS services focus on corrective and preventative actions (CAPA) to meet any and all findings from audits or inspections. CAPA(s) are provided, with follow-up until positive corrections are documented and completed.

Standard Operating Procedures (SOP) describe the critical processes within your pharmacovigilance system. At iVigee, we may review your existing SOPs, develop new SOPs, or perform a batch review for multiple/all SOPs in place impacted by new regulations.

• Comparing your PV system to industry standards 
• Thorough examination of your current pharmacovigilance operating procedures, concludes with feedback and suggestions to further strengthen your Pharmacovigilance System
• Integrating existing pharmacovigilance systems related to acquisitions or global expansions
• Pharmacovigilance vendor management, vendor auditing and compliance reviews
• Integration of Legacy Systems/Data, safety database migrations, harmonization of safety processes and applications, portfolio acquisitions performed in compliance with relevant regulatory requirements