Pharmacovigilance System Master File (PSMF)

PSMF summarizes the PV system of a MAH and is pivotal to a business. EU PV legislation requires that all the companies with applicant/MAH status must develop a PSMF for all their product(s). MIVIGILANCE helps you create and maintain PSMF that accurately and comprehensively describes your company’s PV system. PSMF is paramount to company being compliant as this is shared with EU regulatory authorities and provides an insight into the company’s PV System.

PSMF should be created in the required timeline and signed off by a QPPV, we understand the complexity of this process and breaks it into manageable simple chunks specific to each PV system to ensure easy operations.

Risk Management Plan (RMP)

The Risk Management Plan (RMP) is another important scientific living document that accompanies a product throughout its lifecycle. RMP enlists safety risks, identified and updated, all actions/events regarding efficacy and safety. Our pharmacovigilance (PV) specialists along with our non-clinical, clinical, and quality teams, guide you through the process of developing and maintaining a quality RMP that meets all regulatory requirements.​