We are the market leader in the provision of local contact persons for Pharmacovigilance, Regulatory and QA.
PrimeVigilance harbors an extensive network of local QPPVs and National Persons Responsible for Pharmacovigilance (NPRP) in the EEA countries. We offer a blend of in-house and external resources to serve diverse needs. They can support your program or provide services under our umbrella of PVConsult™ solutions and combined with our physicians, medical writers and project managers, we co-ordinate and oversee a vast array of PV operations.
These include, but are not limited to:
- ICSR intake and processing incl. unblinding services for regulatory reporting. Our Clinical Safety experts can assist you in reaching agreement with regulators concerning serious events that would be treated as disease-related and not subject to routine expedited reporting
- Local submissions and advice on submission options; e.g., a safety variation is triggered for a marketed product (one common scenario is when changes to MEA/category 3 studies are required), whilst an extension of indication procedure is ongoing and a joint Risk Management Plan cannot be submitted
- Fulfill local PV requirements in relevant procedures and systems, such as PSMFs
- Provide PV/product-specific training and assist with local literature screening activities
- Support inspections conducted by Health Authorities or other stakeholders
- Provide direct access to strategic advisors and SMEs; see also our PVExpert™
- Monitor compliance e.g., oversight of risk minimization measures or adjustments and ensure that PV systems are audit-ready
- Provide regulatory intelligence and global consultation in collaboration with Ergomed’s Regulatory Affairs Intelligence and Analytics division: from Mexico’s guidelines on PV reports associated with MA renewal to RWD utilization for drug safety in post-marketing studies in Japan and advise you on how your PV plans might be affected by the Chinese GVP.
Our Extensive Network
>
LCPPVs
+
EU/UK QPPVs and/or Deputies
>
countries
+
clients globally