Does Burna AI generate regulatory reports?

Yes. Three regulatory report types ship today: FDA MedWatch 3500A forms for serious adverse event reporting, IRB Unanticipated Problem reports, and Sponsor SAE reports. Each report type includes compliance tracking, validation rules, supplemental data collection, and a regulatory cascade flag so a single adverse event can be routed to multiple required submissions. Clinical-grade AE Report PDFs include severity-coloured cards, WHO-UMC and Kramer attribution categories, patient context, study site data, and summary statistics suitable for sponsor reporting and audit defense.