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Pharmacovigilance

We help MAH to operate a pharmacovigilance system for the fulfilment of his pharmacovigilance tasks

PSMF creation and management

Implementation and updates to SOPs covering pharmacovigilance processes

Optimize pharmacovigilance processes and interfaces to ensure a proper and timely handling of mandatory activities

Ensure compliance through applying performance indicators and forms with full harmonization with current and upcoming pharmacovigilance requirements

Full preparation RMP, PSUR and risk minimization measures for generics