Pharmacovigilance services Eudravigilance

pharmacovigilance Eudravigilance

We offer you Eudravigilance reporting and pharmacovigilance services. In combination with additional regulatory services for medicinal products we can assure comprehensive support for your projects.

Our offer of pharmacovigilance services:

► preparation of pharmacovigilance system for the future marketing authorization holder

► preparation of Pharmacovigilance System Master File (PSMF) and Risk Management Plan (RMP) for the submission dossier

► registration of MAH in Eudravigilance system

► constant pharmacovigilance services with Eudravigilance reporting

► Periodic Safety Update Reports (PSUR) preparation

► taking role of marketing authorization holder

► other regulatory affairs services (see Consulting).

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