p2d (Prompt-to-Decision)® · CBA (CASE-BASED AGENT)®
Transform weeks of manual review into minutes of draft generation.
Request a demoWatch source documents become a cited, submission-ready draft - from ingestion to generated sections.
RegDoc transforms complex regulatory workflows by converting source evidence and expert reasoning into structured, submission-ready documents in hours, not weeks. Powered by specialized CBA (CASE-BASED AGENT)®™, it synthesizes data, applies regulatory standards, and produces outputs that are fully traceable, compliant, and defensible by design.
Support end-to-end regulatory workflows across drugs, biologics, medical devices, and IVDs, from IND, NDA, and 510(k) submissions to MDR/IVDR technical documentation, CERs, and PSURs. Every output is linked to underlying evidence with built-in traceability across documents and QMS artifacts, enabling consistent, audit-ready submissions with greater confidence and fewer review cycles.