In the area of Pharmacovigilance we provide the following services:

• Provision of Qualified Person Responsible for Pharmacovigilance (QPPV) for the European Economic Area (EEA QPPV) and Deputy EEA QPPV
• MAH registration to the Eudravigilance database
• Management of Individual Case Safety Reports
• Preparation and submission of Aggregate Safety Reports
• Monitoring of product safety
• Organizational issues of Pharmacovigilance department
• (Writing and/or reviewing of Standard Operating Procedures and “Detailed Description of Pharmacovigilance System”)
• Risk Management System
• Pharmacovigilance audits/inspections
• Pharmacovigilance training
• Medical Information