Full PV Outsourcing of a Global Generics Pharma Company
- The company was new founded and took over a significant number of products from another MAHs woman’s health portfolio
- No PV system or other PV related structures where in place
- Local structures needed to be established in 45 countries
- PharmaLex offers:
- Set up of a completely new pharmacovigilance (PV) system including QPPV, LPPVs, PSMF, PV SOP updates, and data migration to new safety database
- Maintenance of the PV System after marketing authorizations were transferred to the new MAH