Periodic Benefit-Risk Evaluation Report (PBRER)
Periodic Safety Update Report (PSUR)
Periodic Adverse Drug Experiences Report (PADER)
Risk Management Plan (REMS)
Annual Safety reports
Company Core Data Sheets (CCDS) updates,
Summary of Product Characteristics (SmPC) review and updates
Literature search and Case processing
Qualified Person for Pharmacovigilance (QPPV) services in Europe
Pharmacovigilance set up and management
Pharmacovigilance

We deliver value, advice and an expert point of view