How does Burna AI support postmarket pharmacovigilance?

The same twelve-agent grading engine processes adverse events on approved drugs. MedDRA coding feeds the terminology layer. E2B(R3) formatting feeds electronic submission to regulators (FDA, EMA, PMDA). MedWatch forms feed US submissions; CIOMS reports feed international submissions. Periodic safety reporting (DSURs for development phase, PSURs for postmarket) is generated from the structured event store. Real-time case processing covers the 7-day and 15-day expedited reporting timelines.