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Genira
All-in-one safety platform

PV.app

AI-driven pharmacovigilance with automated MedDRA coding, ICSR/PSUR/DSUR generation, and direct gateway submissions to FDA, EMA, MHRA.

PV.app processes safety reports from MedWatch, literature, and spontaneous sources with explainable AI. Automated expectedness assessment, case version tracking, and 18+ language support deliver up to 60% faster case completion.

What you get

AI-driven case intake and triage

Automated MedDRA coding & narrative generation

Regulatory gateway submissions (FDA, EMA, MHRA)

Multilingual interface (18+ languages)

Full audit trail and version history

Signal detection across heterogeneous data

Ready to consolidate your eClinical stack?

Talk to us about a 30-minute scoping call. No deck. Just product and your real workflow.