Regulatory Affairs offer:

Collecting, processing and evaluation of ICSR – Individual Case Safety Report.

Fast track reporting of severe adverse drug reactions.

Follow up – spontaneous reporting.

Electronic reporting in Eudravigilance system.

Periodic pharmacovigilance training.

Comprehensive PSUR preparation.

Surveys of medical literature databases and professional journals in the field of Pharmacovigilance.

Local representative of your company in the field of Pharmacovigilance.

QPPV support at your company or outsource QPPV responsibilities.