Regulators now review with AI. Is your filing ready?
In June 2025 the FDA launched Elsa, its agency-wide AI tool, and agentic AI followed in December. That matters for sponsors because the first reader of a filing may now be an algorithm.
An algorithm is consistent. It does not skim, and it does not get tired at page 400. Inconsistencies between sections, missing cross-references and unsupported statements are exactly the sort of thing a machine reader finds quickly.
The practical response is not to guess what the agency tool will flag. It is to give your own team the same advantage: a systematic check that compares sections, tests them against published guidance and shows its evidence.
That is the idea behind an IND gap assessment run before filing. Software drafts the findings, a regulatory expert decides which ones matter, and every statement is linked back to a source so it can be checked.
If an algorithm reads your filing first, have it checked before you send it.
Know where you stand
before you build.
Tell us about your AI initiative or your next filing. We will tell you what a scoped engagement would cover and how it would be priced.