Pharmacovigilance is our core competency.

Our service includes:

• Planning and implementation of an EU compliant Pharmacovigilance System

• Development of PSMF and risk management plans

• Crisis Management Plan and SOP development

• Qualified Person Pharmacovigilance Europe/Stufenplanbeauftragter According to German Drug Law

• E2B compliant drug safety database

• Generation of Periodic Safety Update Reports (PSUR)

• Single Case Management pre- and post approval (Suspected Unexpected Serious Adverse Reaction - SUSAR and Individual Case Safety Reports – ICSR)

• Remote data entry in client’s safety databases

• Pharmacovigilance audits

• Literature Research

• Training