QPPV Office Services

An EU QPPV must be appointed at the time of submitting the Marketing Authorization Application (MAA). The QPPV’s details, along with the summary of the Pharmacovigilance System Master File (PSMF), are included as part of the application dossier.

We carefully manage the number of Marketing Authorization Holders (MAHs) assigned to our EU QPPVs to ensure that they can provide dedicated and focused oversight. The exact number varies depending on the complexity of the products and the specific needs of each MAH, but we prioritize maintaining a manageable workload to ensure high-quality pharmacovigilance services and compliance with regulatory requirements.

Our QPPV office is equipped with PV experts proficient across all major global territories, including the EU/EEA QPPVs, the UK QPPVs, the EAEU-QPPVs, and the Arab QPPV. Additionally, to ensure compliance with PV regulations at the country level, we employ internationally-based PV specialists who serve as Local QPPVs across individual countries.

The timelines for setting up a new Pharmacovigilance (PV) system depend on factors such as the partnership model and the division of responsibilities. If the PV system is fully outsourced to Insuvia and only our SOPs apply, the system can be established in as little as a few weeks. The specific timeline will vary based on the complexity of the setup and collaboration model. Contact us to discuss the details.

Yes, we can either set up and manage a safety database for you or we can work within your existing safety database, depending on your preferences. Our team is highly experienced with various platforms, including Veeva Safety Vault, Argus, and ArisG. We offer comprehensive services such as GxP validation, ensuring regulatory compliance, and managing safety data migration from third-party vendors, providing you with secure and tailored safety data management solutions.