Pharmacovigilance Services
We deliver end-to-end pharmacovigilance solutions to ensure drug safety and regulatory compliance across the entire product lifecycle:
- ICSR intake, processing, MedDRA coding & regulatory submissions
- Aggregate safety reports: PSURs, PBRERs, DSURs
- Signal detection, risk management plans (RMPs), and benefit-risk evaluations
- PV audits, inspection readiness & SOP development
- AI-augmented analytics for faster, more accurate signal detection