Pharmacovigilance Services

 

Local Qualified Person for Pharmacovigilance as required by Article 104(4) of Directive 2001/83/EC

RMP submissions

EudraVigilance registration

Collection of Adverse Events from local literature

Collection of ICSRs / documentation

Medical device vigilance

 

AE follow-up

24-hour availability

PV training for clients' personnel

Regulatory Authority's communication

Reconciliation report