Pharmacovigilance – New

The Marketing Authorisation Holders of a medicinal product are obliged to monitor, collect, assess and report all adverse events during the post-authorisation stage of a medicinal product.

The services SustChem Engineering offers include:

Drafting of Pharmacovigilance System Master File (PSFM File)
Definition of the Pharmacovigilance Quality System
Registration of the company on the Eudravigilance online database

 

Gathering and electronic submission, through Eudravigilance, of Individual Case Safety Reports (ICRS)
Round-the-clock contact person
Preparation for inspections of the pharmacovigilance system