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).
ul. Olesińska 21
Tel./fax +48 22 845 10 34 Mobile +48 691 600 104