Amia delivers the finished work, with strategy included. Our MedNova software does the analysis, and expert reviewers confirm every finding before it reaches you. You receive the deliverable, not another tool to learn.
Software drafts. Experts decide. You receive work you can stand behind.
Why Amia
The status quo, in numbers.
Where the industry stands today.
Speed
About 6 months
to prepare an IND
Cost
$51K to $300K
total to write and draft an IND
Accuracy
Nearly 100%
regulatory compliance of AI-drafted trial documents, up from 70 to 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.
Why now
Regulators now review with AI. Sponsors are still filing blind.
“Submissions that are disorganized, that bury key data, or that require reviewers to synthesize inputs may fare poorly when the first pass is algorithmic.”
Steve Silverman, former Director, FDA CDRH Office of Compliance · What the FDA?
“Elsa's algorithms may detect patterns or anomalies that human reviewers might overlook, leading to new types of information requests or queries that are more data-driven or granular.”
Their advice: anticipate likely questions and supplement your initial filing with responsive data before submission. Agency officials at the 2026 FDLI Annual Meeting were just as direct: expect AI to be applied to your submission and prepare accordingly, per Skadden's meeting report.
If an algorithm reads your filing first, have your filing checked before you send it. That is the work we deliver.
Services
Everything we deliver, across the lifecycle.
Regulatory and validation work on one source-linked foundation. Every statement traces back to your documents and to public sources, and an expert reviews it before it reaches you.
Regulatory
Before you file
IND gap assessmentPrioritized gaps across CMC, nonclinical, and clinical, with predicted reviewer questions labeled as predictions and a recommended action for each gap.
Writing the IND
IND generationIND sections drafted from your source data, with each statement traceable to where it came from, then reviewed and edited by an expert.
In the clinic
Clinical summary reportsClinical data summarized from your study documents, with figures and statements traced back to the source tables and listings.
Validation
Before execution
Protocol generationValidation protocols, such as IQ, OQ, and PQ, drafted from your validation plan and requirements.
After execution
Report generationValidation reports drafted from your executed results, with each statement traced to the data behind it.
Any time
Documentation reviewCompleteness, cross-document consistency, and requirement-to-test traceability checks on documents you already have.
Strategy includedAt every stage, our experts advise on what to do next. It is part of the fee.
How it works
Software first. People before anything reaches you.
Step 1
Scope
We agree the documents, the question you need answered, and the review cycles included, in writing.
Step 2
Analyze
MedNova runs rule checks, retrieves evidence from your documents and public sources, and drafts findings with their sources attached.
Step 3
Review
A regulatory or validation expert confirms, edits, or removes each finding. Nothing is delivered on software output alone.
Step 4
Deliver
You receive the finished work, our strategy recommendations, and a call to walk through it, so your team can act on it.
The software does
Deterministic rule checks, kept separate from AI-assisted 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 report 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
What you receive
A finding you can act on, not a score to interpret.
Three findings from an illustrative gap assessment of a hypothetical sterile injectable IND. Each one states the gap, its basis, what was and was not located, and what to do next.
CriticalCMC
Container closure integrity has not been adequately demonstrated over the proposed shelf life.
NOAEL determination for the most sensitive species not located in supplied documents. Human equivalent dose scaling calculation not identified in documents reviewed.
Recommended action
Provide the NOAEL for each species with supporting toxicokinetic exposure data, and document the human equivalent dose derivation and safety factor applied.
MajorClinical
The dose-escalation protocol does not define stopping rules or dose-limiting toxicity criteria.
Dose-limiting toxicity definition not located in supplied documents. Cohort-level escalation and de-escalation rules not identified in documents reviewed.
Recommended action
Add an explicit definition of dose-limiting toxicity and the criteria for escalating, holding, de-escalating, and stopping dosing.
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.
Illustrative example. Critical, Major, and Minor are Amia's own risk classification, not FDA deficiency classifications. "Not located in supplied documents" means the item was not found in what was provided, not that the evidence does not exist.
Who it is for
For biotech, pharma, and CRO teams.
Biotech
Lean teams that need the filing done and checked without hiring a regulatory function first.
A defined scope and fixed fee, quoted before work starts
No new software to learn or staff to add
Strategy included in the fee
Pharma
Teams that need documents an auditor can follow from the page back to the source.
Source-linked findings and generated text
Deterministic checks kept separate from AI-assisted reasoning
Deployment in your cloud or on premise, by arrangement
CROs and CDMOs
Service providers that need sponsor-ready documents without adding headcount.
Documents delivered to a scope you and the sponsor agree
Validation protocols and reports for your systems
Reviewed by an expert before it leaves you
Pricing model
Pay for the deliverable, not the seat.
There is no license to buy and no software for your team to operate. Each engagement is a defined scope for a fixed fee, quoted on a scoping call.
Scope in writing
The documents reviewed, the review cycles included, and the format of the deliverable are agreed before work starts.
One fee per deliverable
No seats, no per-page meter, and no open-ended hours. You know the cost before we begin.
Strategy is included
Regulatory and validation strategy from our experts is part of the fee. You get direction on what to do next, not only documents.
Fixing is scoped separately
A fixed fee for the assessment does not imply unlimited remediation. Follow-on work is scoped on its own terms.
Trust
Built for work you have to defend.
Traceable and reviewed
Source-linked and traceableMaterial findings are source-linked and traceable, 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 report 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.
Public sources, namedFindings draw on public FDA, EMA, and ICH guidance and regulations, ClinicalTrials.gov, Drugs@FDA, and PubMed, alongside the documents you supply.
Questions
Questions before you book.
Do we need to learn or operate any software?
No. You send the documents in scope and receive a finished report. MedNova supports the work behind the scenes and behind expert review.
Who reviews the findings?
A regulatory or validation expert confirms, edits, or removes each finding before delivery. Software output alone is never the deliverable.
Does this tell us what FDA will ask?
No one can know that in advance. Reviewer questions in our reports are labeled as predictions, and every gap is tied to a source. We do not claim to reproduce or approximate FDA's internal review systems.
What do we need to send?
The documents in scope. For a gap assessment, that is typically the IND sections you have drafted, the nonclinical summary, and the protocol. For IND generation and clinical summary reports, the source data and study documents. For validation, your validation plan, requirements, and executed results, or the protocols and reports to be reviewed. We confirm the list on the scoping call.
How is it priced?
A fixed fee for a defined scope, quoted after a scoping call. Strategy is included in that fee. There are no seats or licenses.
Does this replace our regulatory team?
No. It gives your team a source-linked starting point so they spend time on judgment instead of searching. Accountability for the submission stays with you.
Know where you stand before you file.
Tell us what you are about to submit. We will tell you what a finished assessment would cover and how it would be scoped.
