Pharmacovigilance

Services:

• Writing SOP (Standard Operating Procedures) with templates, logs and forms thereto necessary for functioning of pharmacovigilance and quality department;

• Writing the Master File of the Pharmacovigilance System;

• Personnel trainings for the customer company;

• Writing PSURs (Periodic safety update reports);

• Writing DSURS (Development safety update reports);

• Audit of the pharmacovigilance system with a report and CAPA preparation (Corrective and Preventive Actions);

• Audit of the quality system with a report and CAPA preparation (Corrective and Preventive Actions);

• Monitoring of medical scientific literature and sites of regulatory bodies;

• Obtaining, handling and work with Individual Safety Reports;

• Management of safety signals;

• Consulting on pharmacovigilance and quality;

• Collection and analysis of adverse events in CT;

• Writing Risk Management Reports;

• Handling drug quality complaints;

• Transfer of ADRs to regulatory bodies;

• Medical expertise of safety cases;