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 PSMF in place prior to the submission of a MA 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 QPPVs and technical experts are fully responsible for its creation, maintenance, and ensuring your PV system remains fully compliant with European and International regulations and guidelines.

Local PSMF.

Many countries around the world have additional local requirements of the PSMF e.g., France for example dictates specific requirements for a global PV system; and 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.

Selected PV Case Studies.

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ICSRs, Local literature screening, Regulatory intelligence
Strategic Planning case study
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system TH
Local PV, regulatory strategy
Complex pharmacovigilance local support