About Us

Built so sponsors see their gaps first.

MedNova is a product of Amia.ai. It reviews an IND against the applicable regulations and the sponsor's own evidence before the filing reaches a reviewer.

Who we are

A regulatory intelligence workspace, from Amia.ai.

Amia.ai builds AI for healthcare and life sciences. MedNova is its regulatory intelligence workspace for pharma and biotech teams preparing submissions to FDA and EMA.

MedNova analyzes your IND against regulatory requirements and your supporting evidence, surfacing potential gaps and reviewer-style questions before submission. Each finding is mapped to its regulatory basis, the evidence located or not located, the question a reviewer is likely to ask, and a recommended remediation.

MedNova is a regulatory intelligence workspace, not a substitute for qualified regulatory judgment.

Why we built MedNova

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

If an algorithm reads your filing first, run one before you send it.

The agency sees the gaps first

FDA officials report AI-assisted review now completes certain scientific review tasks in minutes that once took days. Gaps, weak justifications, and inconsistencies that a team missed surface as amendments and information requests after filing. FDA press announcement, May 2025

Less room to clarify after the fact

Counsel advising sponsors on FDA's AI systems expect less opportunity for iterative clarification with a reviewer. Ambiguity a human might have resolved in a call can arrive instead as a formal information request, on the agency's clock.

So we started with the review

MedNova begins with gap analysis: what is missing, inconsistent, unsupported, or insufficiently explained, with the regulation behind each finding and the evidence that answers it. Read the full briefing on the home page.

Mission

Know where you stand before you file.

Our principles are the ones already written into the product.

Rules check. AI reasons. Humans approve.Deterministic checks are kept separate from AI-assisted regulatory reasoning, and qualified regulatory professionals review and approve material before it is used in a submission.
Every claim cites its sourceFindings map to applicable regulatory sources and to supporting evidence with document-level traceability.
"Not found" is not "doesn't exist""Not found" means not located in the supplied documents, not that the evidence does not exist.
We say what we don't doMedNova does not predict every agency question, guarantee filing acceptance or approval, treat regulatory precedent as a substitute for sponsor data, or replace qualified regulatory review.
"Clear" is not acceptance"Clear" means no material gap identified against the evaluated rule set and documents reviewed. It does not mean FDA will accept or approve the submission.
Your data stays yoursPrivate deployment, with a private model mode by default and external models only with approval.

AI + regulatory experience

Two disciplines in one workspace.

Regulatory

Section-specific regulatory playbooks
Grounded in curated regulatory and clinical sources
Regulatory precedent, cited and traceable
Qualified human review before anything is used in a submission

AI and engineering

Deterministic rules check consistency and completeness
AI-assisted regulatory reasoning evaluates support and applicable expectations
Evidence retrieval across public and licensed sources in one pass
Private deployment, complete and versioned audit history

Leadership

Led by the founder of Amia.ai.

Louis Lalas

Founder & CEO, Amia.ai

Louis leads Amia.ai and MedNova. He takes the demo calls himself, so the fastest way to meet the team is to book a 30-minute session.

Book a Demo contact@amia.ai

See your gaps before FDA does.

A short session to walk your team through MedNova and find the right first program.

Book a Demo Contact Us

Louis Lalas, Founder & CEO, Amia.ai