The Auriga Safety System is a cloud-based, all-in-one pharmacovigilance and drug safety platform — designed for CDSCO compliance and global E2B(R3) submissions.
Request a Live DemoThe Auriga Safety System is built on a modern, cloud-hosted infrastructure accessible from any device. It provides a complete pharmacovigilance workflow from case receipt to regulatory submission — with role-based access for both the Auriga PV team and the MAH client.
End-to-end PV workflow in a single integrated system
Multi-channel adverse event receipt — email, web form, EDC integration, literature monitoring feeds and spontaneous reporting.
Structured case entry, duplicate detection, MedDRA coding, seriousness assessment, and narrative authoring — with full audit trail.
AI-assisted case narrative generation, automated MedDRA coding suggestions, and intelligent duplicate flagging to reduce processing time.
Real-time safety analytics: ICSR volume trends, time-to-report metrics, signal indicators, and MedDRA PT frequency heat maps.
Automated E2B(R3) XML generation with built-in validation and direct AS2/gateway transmission to EMA, FDA and MHRA.
Automated line listings, summary tabulations and data extracts for PSUR, PBRER and DSUR report preparation.
Statistical signal detection algorithms (PRR, ROR, IC) applied to cumulative safety data, with Signal Tracking Register built in.
Document Management System for SOP storage, version control, training records and PvMF documentation — accessible to both teams.
Full compliance coverage across global regulatory standards
| Standard / Regulation | Region | Coverage |
|---|---|---|
| ICH E2B(R3) | Global | Electronic ICSR reporting standard — XML format and messaging |
| CDSCO / NDCT Rules 2019 | India | ICSRs and PSURs for marketed drugs |
| EU GVP Modules | Europe | I–XVI — all aspects of pharmacovigilance |
| 21 CFR Part 314 | USA | FDA post-marketing safety reporting |
| UK MHRA Yellow Card | UK | Post-Brexit ICSR submissions |
| WHO-UMC / VigiBase | Global | International safety database submissions |
Request a free live demonstration — we'll show you exactly how the platform handles your product portfolio.
Request a Live Demo