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 from MedWatch, Literature, Spontaneous sources
Automated MedDRA coding with 60% faster case processing
Automated expectedness assessment for consistent evaluation
Flexible forms and workflows without custom development
Multilingual interface in 18+ languages for global teams
Regulatory gateway submissions (FDA, EMA, MHRA)
Case version tracking for full traceability and audit readiness
Automated workflow alerts and reminders for timely handling
Ready to consolidate your eClinical stack?
Talk to us about a 30-minute scoping call. No deck. Just product and your real workflow.