About 6 months
to prepare an IND today
Why Amia
Software drafts. Experts decide.
We combine AI speed with regulatory-grade expert review, so you receive work you can stand behind — not another tool to learn or a score to interpret.
The delivery model
Services as software.
AI does the heavy lifting — rule checks, retrieval, first-draft findings with sources attached. Accountable experts review everything before it reaches you. You get the finished deliverable, with strategy included.
Built around Source-traced outputs Expert review loops Deterministic + AI checks RBAC & audit logging AWS · Azure · GCP 21 CFR Part 11-aware
The software does
- Deterministic rule checks, kept separate from AI reasoning
- Retrieval of evidence from your documents and public sources
- First-draft findings with a source attached to each one
People do
- Decide which findings are real and how serious they are
- Own the final work you receive
- Answer your questions and walk your team through it
We do not
- Claim to reproduce or approximate FDA's internal systems
- Predict every question a reviewer will ask
- Treat "not located" as proof that evidence does not exist
Why now
The ground has shifted.
FDA launched Elsa, its agency-wide AI tool, in June 2025; agentic AI followed in December. Regulators now review with AI, and the way work gets prepared has to keep up.
What makes Amia different
Built for work you have to defend.
Traceable and reviewed
- Source-linked and traceableMaterial findings are source-linked, so your team and your auditors can follow each one back to where it came from.
- People sign offAn expert reviews every finding and every generated document. The software drafts and checks; accountable people decide.
- Honest about absenceWe write "not located in supplied documents," not "does not exist," unless we have authoritative knowledge that it does not.
Responsible by design
- Two kinds of checks, labeledDeterministic rule checks and AI-assisted reasoning are kept separate, and the deliverable tells you which produced which finding.
- Your documents stay yoursData handling is configured to your enterprise and GxP controls. Deployment in your cloud (AWS, Azure, or GCP) or on premise is available by arrangement.
- Confidentiality-firstA regulated-industry focus, with confidentiality built into how we scope, handle data, and reference prior work.
The status quo, in numbers Speed Cost Accuracy FDA AI, aka Elsa
Where the industry stands.
$51K–$300K
total to write and draft an IND
Nearly 100%
regulatory compliance of AI-drafted trial documents, up from 70–80% for a general-purpose chatbot
2025
FDA launched Elsa, its agency-wide AI tool, in June. Agentic AI followed in December.
Know where you stand.
Tell us what you are working on. We will tell you what a scoped engagement would cover and how it would be priced.