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
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