Secure your EU/UK QPPV and Local Contact Persons (LCPPV) with our extensive global network. We provide reliable PSMF maintenance and local regulatory intelligence in over 100 countries.

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PrimeVigilance provides a robust network of qualified persons (QPPVs) and local safety officers to ensure constant compliance. We handle the full lifecycle of your Pharmacovigilance System Master File (PSMF), ensuring it remains audit-ready at all times. Whether for a single region or global coverage, our experts act as your regulatory interface, managing compliance risks effectively.

  • Our QPPVs provide general pharmacovigilance consultancy in addition to the QPPV oversight role and can effectively advise on additional PV, risk management plan/risk minimization activities over the lifecycle of your product.
  • PrimeVigilance has extensive experience in Pharmacovigilance System Master File (PSMF) and PV Safety Data Exchange Agreements (SDEA) authoring, optimization and management ensuring efficiencies in negotiating and complying with PV Agreements (PVAs).
  • Our experts have assisted clients throughout all four phases of the PVA process: pre-PVA, PVA creation, implementation, as well as maintenance and termination. We believe in creating practical SDEAs/PVAs and in monitoring compliance which guarantee effective negotiations among stakeholders and timely amendments.
  • We review the pharmacovigilance agreements of drug-device combination (DDC) products with suppliers to ensure that they take into consideration additional data that may need to be collected and communicated, such as device malfunctions and device-related events.

Our experienced EU QPPVs and technical experts:

  • Are well-versed in developing and maintaining inspection ready PSMFs associated with one or more authorized medicinal products
  • Ascertain specific regional requirements and ensure that your PV system remains fully compliant. In Europe, changes to the summary of PV system and/or changes in PSMF will be notified by our dedicated resources through the Article 57 database (XEVMPD).