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Pharmacovigilance
Pharmacovigilance at Adveesan Consulting offers a broad range of services including:
PV Medical Writing Services
Periodic Benefit-Risk Evaluation Report (PBRER)
Periodic Safety Update Report (PSUR)
Periodic Adverse Drug Experiences Report (PADER)
Risk Management Plan (RMP)
Annual Safety reports
Literature search and Case processing, Signal Detection
Company Core Data Sheets (CCDS) updates
Summary of Product Characteristics (SmPC) review and updates
Qualified Person for Pharmacovigilance (QPPV) services in Europe
Pharmacovigilance set up and management
Pharmacovigilance Audits and Gap Analysis