Pharmacovigilance
End-to-end drug safety solutions ensuring regulatory compliance and patient protection.
Pharmacovigilance & Risk Management
• ICSR Case Management (collection, processing & reporting)
• Signal detection & benefit–risk evaluation
• Aggregate report writing — DSURs, PSURs/PBRERs
• Literature monitoring & medical review
• Risk Management Plans (RMP) — creation & execution
• PSMF setup, maintenance & governance
• QPPV / Local Safety Officer support
• PV audits & inspection readiness programs