What an IND gap assessment catches, and why to run one before you file
An IND is written by many hands: chemistry, nonclinical, clinical and regulatory teams each contribute sections, often on different timelines. The gaps appear at the seams.
A gap assessment reads the whole package against guidance and flags what is missing, what disagrees with another section and what is stated without support. Findings are ranked by severity, so the team spends its time on the critical items first.
Preparing an IND commonly takes about six months and costs from $51K to $300K. Finding a critical gap after submission means delay on top of that, plus additional scrutiny.
The value of the assessment is not that software is smarter than your writers. It is that a second reader, with a rule set that does not change from one run to the next, reviews everything, and shows the evidence for each finding.
Our approach keeps deterministic rule checks separate from AI reasoning, and has an expert review every finding before it reaches you.
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.