QPPV: Qualified Person for Pharmacovigilance (QPPV/Deputy QPPV): pharmacovigilance support for SME Marketing Authorisation holders; take the pressure off internal experts in this crucial area.
Adverse Event investigation & reporting: Veterinarian with Pharmacovigilance experience, independent AE investigation, handling and reporting through your database or EVWEB.
Periodic Safety Update Reports: PSUR drafting to NTA Volume 9B requirements based on your PV data and literature review.
PV Data resource optimisation: PV data is a resource-draining obligation, but also a database of knowledge on your products. Use your PV data to support your regulatory management strategies.