NOVA
Novel Observation & Validation Assistant
Pharma AI that understands
the language of drug regulation.
NOVA is trained on CDSCO, FDA 21 CFR, and EMA guidelines, ICH E2A through E2F safety reporting standards, MedDRA medical terminology, eCTD v4.0 submission structure, GMP and GLP requirements, ICH-GCP principles, and deep operational knowledge of global regulatory programmes.
When NOVA identifies a gap in a submission dossier, it knows which section, which data requirement, and which authority's format is missing. When SafeWatch flags a signal, NOVA's MedDRA knowledge ensures the coding is accurate - not approximate. Approximate is not acceptable in drug safety.
Full NOVA deep-dive page ->