Pvgenix

PVgenix is a GxP-compliant pharmacovigilance SaaS platform built for drug safety and regulatory teams. The platform covers the full PV lifecycle — AI-assisted ICSR intake, E2B (R2/R3) case management, MedDRA & WHO-DD coding, AS2 gateway transmission to FDA ESG and EudraVigilance, signal detection (PRR, ROR, IC/BCPNN, EBGM), aggregate reporting, and QMS.
Designed to be validation-ready, PVgenix ships with a complete GxP/CSV documentation package (VMP, URS, FS, DS, IQ/OQ/PQ, RTM) aligned to 21 CFR Part 11 and GAMP 5, so safety teams can validate and deploy faster.
PVgenix is powered by Bright Infonet, a software development company specializing in regulated pharma and life-sciences technology.