Pharmacovigilance

Services

Our Pharmacovigilance services ensure continuous monitoring of the safety of medicinal products, from early development through post-marketing.

We support Marketing Authorisation Holders with robust safety operations, including case management, signal detection and evaluation, global literature monitoring, and the preparation of regulatory safety reports.

We provide flexible, reliable solutions tailored to each company’s needs, ensuring full compliance with EMA, FDA and international PV requirements. If your organisation is looking for expert support to strengthen its safety system, our team will be pleased to assist you.

EU and Local QPPV Services

ICSR Management & Medical Review

Signal Detection and Management (including EVDAS)

PSUR, RMP and other Safety Reports

Pharmacovigilance System Master File (PSMF)

Safety Database Management

SDEA Management and Regulatory Consultancy

Post-Authorization Safety Studies (PASS)

XEVMPD and IDMP Compliance

Quality Management and SOP Development