New Regulators now review with AI — we get your work ready for it.

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.

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Trusted approach Source-traced Expert-reviewed On your cloud
mednova.ai / workspace
The MedNova workspace: a readiness panel and a critical CMC finding on container closure integrity, with its regulatory basis, evidence not located in supplied documents, a predicted reviewer question, and a recommended action.
Expert-reviewed every finding Source-traced to the page
What we do

Three practice areas, one delivery model.

AI that reaches production with experts in the loop. Every engagement is scoped in writing and delivered as finished work — strategy included.

AI Consulting & Development

From idea to production agentic AI — experts in the loop.

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Regulatory AI Workflows

IND, clinical, and validation work — drafted, source-traced, reviewed.

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Enterprise AI Automation

Custom agents and managed AI ops on your infrastructure.

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The status quo, in numbers

Why the economics are changing.

0
to prepare an IND today
0
upper end to write & draft an IND
0
compliance of AI-drafted docs, near
2025
FDA launched Elsa, its agency AI

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.

  • Source-traced Every statement links back to your data and public sources.
  • Expert-reviewed A regulatory or validation expert signs off before delivery.
  • On your cloud Deployed on AWS, Azure, or GCP — or on premise, by arrangement.
  • 21 CFR Part 11-aware Documentation built for audit from the first draft.
A closer look

What delivery looks like.

The same governed foundation across every engagement — retrieval with human review, deterministic checks kept separate from AI reasoning, and sources attached to every statement.

Capabilities

The stack behind the work.

Custom AI agents

Goal-directed agents that plan, retrieve, and act across your systems — with guardrails and human checkpoints.

Document intelligence

Extraction, classification, and summarization over document-heavy processes, every statement traced to its source.

Retrieval + human review

Answers grounded in sources you approve, with expert review loops before anything is trusted.

Evaluation & monitoring

Evaluation baked in from the pilot, with performance tracking and model updates in production.

Governed by default

Role-based access control, audit logging, and deterministic checks kept separate from AI reasoning.

On your infrastructure

Platform-agnostic across AWS, Azure, and GCP — deployed in your cloud or on premise by arrangement.

Gloved hands recording results beside a tray of labeled pharmaceutical sample bottles in a regulated laboratory.
Why now

Regulators now review with AI.
Sponsors are still filing blind.

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.

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Industries

Built for regulated work.

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.

Lead industry

Pharma & Life Sciences

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 industry

And the industries around it

  • Biotech
  • CROs & CDMOs
  • Medical Device
  • Regulated Enterprise

Same governance-first architecture — retrieval with human review, deterministic checks kept separate from AI reasoning, and deployment on your infrastructure.

How we deliver

Assess. Pilot. Build & deploy. Run.

A four-step model that gets AI into production on your infrastructure, with accountable experts reviewing the work before it reaches you.

  1. Step 01

    Assess

    We agree the scope, the question you need answered, and the review cycles included, in writing.

  2. Step 02

    Pilot

    A focused pilot proves the workflow on your data before any broader build or commitment.

  3. Step 03

    Build & Deploy

    We build the production system on your infrastructure, with evaluation and monitoring baked in.

  4. Step 04

    Run & Support

    We operate, monitor, and improve it — model updates, performance tracking, and expert review on call.

Testimonials

What a finished engagement feels like.

Example quotes shown to illustrate the outcome. We replace these with real, attributed, approved testimonials before launch — we don't publish endorsements we can't stand behind.

Sample
“We went into our pre-IND meeting knowing exactly where the gaps were. The assessment flagged a CMC issue we would have missed until the FDA raised it.”
VP, Regulatory AffairsClinical-stage biotech
Sample
“A three-month validation backlog turned into a two-week turnaround. Every report traced back to our data, so QA signed off without rework.”
Head of QualityMid-size CDMO
Sample
“The documents came back submission-ready, source-linked, and reviewed by someone who has actually filed INDs. It felt like adding a regulatory team overnight.”
FounderEmerging biotech
Credibility

Deep roots in regulated life sciences.

Experience in pharma & life sciences

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.

Why Amia

The status quo, in detail.

Speed

About 6 months

to prepare an IND today

Cost

$51K–$300K

total to write and draft an IND

Accuracy

Nearly 100%

regulatory compliance of AI-drafted trial documents, up from 70–80% for a general-purpose chatbot

FDA AI, aka Elsa

2025

FDA launched Elsa, its agency-wide AI tool, in June. Agentic AI followed in December.

Expert-led, software-assisted

Software drafts. Experts decide. You receive work you can stand behind.

The platform behind the work

MedNova is the product platform behind our regulated life sciences work.

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.

  • 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
The MedNova demonstration workspace: a readiness panel on the left and, on the right, a critical CMC finding on container closure integrity with its regulatory basis, evidence, a predicted reviewer question, and a recommended action.

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.

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.

Book a scoping call Email us