Our QPPVs not only fulfil their oversight role, they offer PV consultancy over the lifecycle of your product as well.
Our team of 30 EU/UK QPPVs and their deputies, as well as over 300 local contact persons responsible for PV can help you set up and maintain complex global PV systems and participate in non-routine PV activities. Their expertise spans decades of industry experience, together with in-depth knowledge of industry trends and regulations.
- Our QPPVs can provide general PV 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 and management.
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).