Pharmacovigilance

The marketing authorization holders of a medicinal product are obliged to observe, gather, assess and report all the unwanted incidents during the post-authorization stage of a medicinal product.  SustChem can offer you all the required services as they are defined by the legislation concerning Pharmacovigilance.  

More specifically:

Conduct of Pharmacovigilance System Master File (PSFM File)
Definition of the Pharmacovigilance Quality System
Registration of the company to the electronic base of Eudravigilance
Gathering and electronic submission, through Eudravigilance, of the Individual Case Safety Reports (ICRS)
Communication Responsible on a 24h basis
Preparation for inspections of the pharmacovigilance system