At Azierta, our team ensures that the management of Pharmacovigilance complies with all the requirements described in Best Practices of PV in the EU (GVP).
We advise on:
- The complete management and monitoring of spontaneous adverse reactions, including medical evaluation.
- Bibliographic searches.
- Safety Reports: PSUR, ACO, RMP, DSUR.
- Design, registration, implementation, and maintenance of the Pharmacovigilance System Master File (PSMF).
- Signal detection.
- Local contact for Pharmacovigilance.
- 24/7/365 contact for Pharmacovigilance.
- Medical Device Vigilance.
We can also provide support in all post-marketing pharmacovigilance activities outside the EU.