Pharmacovigilance System Master File (PSMF).
Your PSMF is critical. Why you should choose us to manage it.
Every Marketing Authorization Holder or Applicant must have a Pharmacovigilance System Master File (PSMF) in place prior to the submission of a Marketing Authorization Application.
A PSMF should be readily available in case of audit or inspection and should contain a detailed description of the PV system, documenting the performance, oversight, and compliance with all legal requirements.
When you choose us to manage your PSMF, our team of experienced EU QPPV’s and technical experts are fully responsible for its creation, maintenance, and ensuring your PV system is fully compliant with European and International regulations and guidelines.
Many countries around the world have additional local requirements to your PSMF to consider. France for example dictates specific requirements for a global PV system. Brazil requires a PSMF to be in Portuguese.
Our global reach and experience, combined with extensive local regulatory intelligence, allows us to prepare a standalone local PSMF or annexes to a global PSMF that meets all these local authority requirements while maintaining a robust and centralized PV system.