Assess
We agree the scope, the question you need answered, and the review cycles included, in writing.
Regulators now review with AI
Regulatory &validation work,delivered.
Amia drafts your IND, clinical, and validation documents with AI, then regulatory experts review every finding before it reaches you. Submission-ready work for biotech and pharma teams, without adding headcount.
- IND · Clinical · Validation
- Source-traced
- Expert-reviewed
- 21 CFR Part 11-aware
How we deliverBuilt layer by layer.
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02
03
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Built layer by layer.
Nothing skipped.
A four-step model that gets AI into production on your infrastructure, with accountable experts reviewing the work before it reaches you.
Pilot
A focused pilot proves the workflow on your data before any broader build or commitment.
Build & Deploy
We build the production system on your infrastructure, with evaluation and monitoring baked in.
Run & Support
We operate, monitor, and improve it: model updates, performance tracking, and expert review on call.
Customer validationProven where the stakes
Enterprise engagement
Enterprise engagement
IND gap analysis
Proven where the stakes
are highest.
From a multi-billion-dollar bioprocessing leader to a clinical-stage biotech, here is what partners say after putting Amia's work in front of their regulators.
Enterprise validation for accuracy & data traceability
The tool demonstrated strong accuracy against the client’s golden output, including placeholder filling and table population, and showed a reproducible, traceable approach to report generation.
Chief Scientific Officer$6B global leader in bioprocessing technologies & biopharmaceutical manufacturing solutions
Company and executive identity available to qualified investors under a signed NDA, subject to disclosure authorization.
Enterprise execution & team excellence
Amia.ai demonstrated exceptional responsiveness to evolving requirements, rapidly adapted to our specific technical documentation needs, and maintained a collaborative, solutions-oriented team culture throughout the engagement. Their ability to execute and adapt made them a strong technology partner.
Executive DirectorLarge biopharma company, Massachusetts
Company and executive identity available to qualified investors under a signed NDA, subject to disclosure authorization.
Find what your regulatory team might miss, before the FDA does.
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 OfficerSan Diego–based clinical-stage biotechnology company
MedNova is refreshed weekly to stay current with evolving regulatory requirements and guidance. Company and executive identity available to qualified investors under a signed NDA, subject to disclosure authorization.
Testimonials 1 and 2 are from the same enterprise engagement.
The status quo, in numbersWhy the economics
Why the economics
are changing.
6 moto prepare an IND today
$300Kupper end to write & draft an IND ($51K at the low end)
100%regulatory compliance of AI-drafted docs, near (vs 70–80% for a general-purpose chatbot)
2025FDA launched Elsa, its agency-wide AI, in June. Agentic AI followed in December.
Figures reflect the current industry status quo.
The platform behind the workSoftware drafts.
Software drafts.
Experts decide.
MedNova is Amia’s regulatory analysis platform. It runs the rule checks, retrieves evidence from your documents and public sources, and drafts findings with their sources attached. In our service, you never operate it: an expert reviews every finding before it reaches you.
- Deterministic checks kept separate from AI-assisted reasoning
- Every material finding source-linked and traceable
- Deploy in your cloud (AWS, Azure, GCP) or on premise
Why nowRegulators now review with AI.
Regulators now review with AI.
Sponsors are still filing blind.
If an algorithm reads your filing first, have it checked before you send it.
Ready when you areKnow where you stand
Know where you stand
before you build.
Tell us about your AI initiative or your next filing. We’ll tell you what a scoped engagement would cover and how it would be priced.