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.
From a multi-billion-dollar bioprocessing leader to clinical-stage biotech — here's what partners say after putting Amia's work in front of their regulators.
“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.”
Company and executive identity available to qualified investors under a signed NDA, subject to disclosure authorization.
“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.”
Company and executive identity available to qualified investors under a signed NDA, subject to disclosure authorization.
“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.”
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.
AI that reaches production with experts in the loop. Every engagement is scoped in writing and delivered as finished work — strategy included.
Figures reflect the current industry status quo. Accuracy figure: regulatory compliance of AI-drafted trial documents, up from 70–80% for a general-purpose chatbot.
The same governed foundation across every engagement — retrieval with human review, deterministic checks kept separate from AI reasoning, and sources attached to every statement.
Goal-directed agents that plan, retrieve, and act across your systems — with guardrails and human checkpoints.
Extraction, classification, and summarization over document-heavy processes, every statement traced to its source.
Answers grounded in sources you approve, with expert review loops before anything is trusted.
Evaluation baked in from the pilot, with performance tracking and model updates in production.
Role-based access control, audit logging, and deterministic checks kept separate from AI reasoning.
Platform-agnostic across AWS, Azure, and GCP — deployed in your cloud or on premise by arrangement.
FDA launched Elsa, its agency-wide AI tool, in June 2025, with agentic AI following in December. If an algorithm reads your filing first, have it checked before you send it.
We lead with pharma and life sciences, and bring the same governed, source-traced approach to every industry where the documentation has to hold up.
AI across the value chain — R&D, regulatory, clinical, and validation. IND gap assessments, drafting support, clinical summaries, and audit-ready validation docs.
Explore the industrySame governance-first architecture — retrieval with human review, deterministic checks kept separate from AI reasoning, and deployment on your infrastructure.
A four-step model that gets AI into production on your infrastructure, with accountable experts reviewing the work before it reaches you.
We agree the scope, the question you need answered, and the review cycles included, in writing.
A focused pilot proves the workflow on your data before any broader build or commitment.
We build the production system on your infrastructure, with evaluation and monitoring baked in.
We operate, monitor, and improve it — model updates, performance tracking, and expert review on call.
Our team's individual experience spans large-cap pharmaceutical and biotechnology organizations across regulatory, clinical, and validation work.
Additional project details and professional references may be provided upon request, subject to confidentiality and prior approval.
About 6 months
to prepare an IND today
$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.
Software drafts. Experts decide. You receive work you can stand behind.
MedNova 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.
Screenshot of the MedNova demonstration workspace, using a hypothetical sterile injectable IND and demo data. In our service, an expert reviews every finding before it reaches you.
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.