The challenge
An IND is assembled from many documents written by different people. Gaps and inconsistencies surface late, when they are expensive: preparing an IND commonly takes about six months and costs between $51K and $300K. Teams needed a second reader that never gets tired, and that shows its work.
What we built
- A rule engine for deterministic checks, kept separate from the AI reasoning so that checks are repeatable
- Retrieval over the sponsor's own documents and public regulatory sources
- Findings ranked by severity (critical, major, minor) with the evidence and the regulatory precedent attached
- An expert review step: in our service, a regulatory expert reviews every finding before it reaches the client
- Deployment options in the client's own cloud (AWS, Azure, GCP) or on premise
Outcome
A CEO of a San Diego-based clinical-stage biotechnology company reported that the analysis surfaced critical gaps and missing elements their regulatory writers had overlooked.
Amia's MedNova IND gap analysis identified several critical gaps and missing elements that our regulatory writers had overlooked. Without these findings, we could have submitted an IND containing incomplete or inaccurate information, potentially leading to costly delays and additional FDA scrutiny.Chief Executive Officer, San Diego-based clinical-stage biotechnology company
Screenshot shows a hypothetical sterile injectable IND with demo data.