MedNova
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Product

One workspace. From gap to filing language.

Upload an IND section. MedNova runs the gap analysis, maps each finding to its regulatory basis, retrieves your supporting evidence, and recommends remediation, all in one traceable loop.

Product overview

Every finding comes with its basis, its evidence, and the question it will draw.

Five parts, always together. Nothing is reported without the regulation behind it and the evidence that answers it.

  1. 01

    Your gap

    What is missing, inconsistent, unsupported, or insufficiently explained.

  2. 02

    Regulatory basis

    The applicable regulation, guidance, or standard, with its citation.

  3. 03

    Your evidence

    The supporting data in your documents, or what was not located.

  4. 04

    Reviewer question

    A predicted question an agency reviewer may raise.

  5. 05

    Remediation

    A recommended action, from a writing fix to additional data.

Anatomy of a finding

What a MedNova finding looks like.

One Critical CMC finding from the demonstration, with every part of the loop in place. The full interactive gap analysis, with all five findings, runs on the home page.

Regulatory basis
21 CFR 312.23(a)(7)(iv)(b) · USP <1207> FDA Phase 1 IND content guidance, 1995 · FDA CCIT guidance, 2008
CMC evidence
  • CCIT method validation/qualification data not located in supplied documents
  • Method detection capability/sensitivity not identified in documents reviewed
  • Shelf-life CCIT data not located in supplied documents
Regulatory precedent

FDA has cited failure to demonstrate container-closure integrity throughout the labeled shelf life in a CGMP warning letter issued after an inspection of a sterile drug manufacturer. FDA warning letter to Lernapharm (Loris) Inc., 2018

Potential reviewer question (predicted)

Provide data demonstrating container-closure integrity throughout the proposed shelf life and describe the CCIT method, including its qualification/validation and detection capability.

Recommended action

Provide qualified/validated CCIT methodology and supporting data covering the proposed container-closure configuration and shelf life.

Resolution type Additional validation data

Illustrative demonstration on an example IND section. Material findings are source-linked and traceable.

"Not found" means not located in the supplied documents, not that the evidence does not exist.

Run the interactive gap analysis

Capabilities

What MedNova does, and what it leaves to you.

What MedNova does

  • Identifies potential filing and evidence gaps
  • Checks consistency across submission content and supporting documents
  • Maps findings to applicable regulatory sources
  • Retrieves supporting evidence with document-level traceability
  • Distinguishes documentation issues from missing-data gaps
  • Generates potential reviewer-style questions
  • Recommends remediation
  • Assists with revised filing language for qualified human review

MedNova supports, it doesn't replace, regulatory judgment

MedNova does not:

  • Predict every agency question
  • Guarantee filing acceptance or approval
  • Treat regulatory precedent as a substitute for sponsor data
  • Replace qualified regulatory review

AI workflow

Rules check. AI reasons. Humans approve.

MedNova separates deterministic checks from AI-assisted regulatory reasoning, and it tells you the difference between a writing fix and a missing-data gap.

  1. 01

    Upload your submission material

    Select an IND section and relevant supporting source documents.

  2. 02

    Regulatory gap analysis

    Deterministic rules and AI-assisted regulatory reasoning evaluate completeness, consistency, support, and applicable regulatory expectations.

  3. 03

    Evidence retrieval

    MedNova traces findings to supporting source documents and distinguishes documentation deficiencies from missing supporting data.

  4. 04

    Reviewer-style assessment

    MedNova generates potential reviewer questions and recommended remediation, with traceability to the underlying finding and regulatory basis.

  5. 05

    Human review

    Qualified regulatory professionals review and approve material before it is used in a submission.

Every output lands in one of three states

  • Clear

    No material gap identified against the evaluated rule set and documents reviewed.

  • Conditionally clear

    A potential deficiency appears addressable with existing evidence, clarification, or improved filing language.

  • Evidence required

    The gap cannot reasonably be resolved by rewriting alone and appears to need additional data, analysis, or validation.

“Clear” does not mean FDA will accept or approve the submission.

Regulatory document intelligence

Every reviewer question has an answer. We bring it to the gap.

Regulatory teams hunt across a dozen databases to back a single claim. MedNova queries them all in one pass, so the evidence is already waiting at the gap.

  • Sources current through Aug 2026
  • 600K+ studies
  • 20K+ products
  • 40M+ citations
  • 2,800+ guidances
  • FDA decision letters
  • licensed intelligence

The 80/20 of regulatory evidence

600K+

ClinicalTrials.gov

registered studies and posted results

20K+

Drugs@FDA

approved products with review packages

40M+

PubMed

biomedical citations and abstracts

Three sources cover most of what a reviewer looks for. MedNova queries all three, plus your own documents, FDA guidance, and licensed regulatory and drug-development intelligence, in one pass.

FDA decision letters. On the roadmap: analysis of the Complete Response Letters FDA has begun publishing and of refuse-to-file letters that have become public, to sharpen what a reviewer will ask.

The gap: the filing does not demonstrate container closure integrity. MedNova pulls the evidence from every source at once. 5 sources queried · 3 cited
Evidence flowing from data sources into a regulatory gap Six sources, ClinicalTrials.gov, your documents, Drugs@FDA, PubMed, FDA guidance, and licensed intelligence, connect to one gap: the filing does not demonstrate container closure integrity. The gap lists its evidence, regulatory basis, and precedent. ClinicalTrials.gov 600K+ registered studies Your documents your filing + source records Drugs@FDA 20K+ approved products PubMed 40M+ citations FDA guidance 2,800+ active guidances Licensed intelligence curated answers + drug history THE GAP Container closure integrity is not validated. TRACEABLE SOURCES EVIDENCE CCIT method validation REGULATORY BASIS 21 CFR 312.23(a)(7)(iv)(b) · USP <1207> PRECEDENT Comparable vial products
The gap: the filing does not demonstrate container closure integrity.
  • Evidence: CCIT method validation · your documents
  • Basis: 21 CFR 312.23(a)(7)(iv)(b) · USP <1207> · FDA guidance
  • Precedent: Comparable vial products · Drugs@FDA

Counts are public figures as of August 2026. Licensed regulatory and drug-development intelligence extends the public sources. Not every gap needs every source; MedNova queries them all and cites only what applies.

A general-purpose chatbot

  • Trained on the open internet
  • No source traceability
  • Can invent references
  • No regulatory playbooks
  • Your data feeds a shared model

MedNova

  • Grounded in curated regulatory and clinical sources
  • Every claim cites its source
  • Deterministic rules check consistency and completeness
  • Section-specific regulatory playbooks
  • Private deployment, your data stays yours

Compliance & security

Built for regulated work.

  • 21 CFR Part 11e-signatures, audit trail, controlled documents
  • Private deploymentyour data stays in a dedicated Nebius environment
  • Model independenceprivate mode by default; external models only with approval
  • Source traceabilityevery claim ties back to its source passage
  • Human approvala qualified expert reviews every output
  • Audit historycomplete, versioned, inspection-ready

Use cases

Start with a gap snapshot.

Three ways teams work with MedNova, from a single scored module to an ongoing retainer.

Gap snapshot

A scored gap analysis on one module. A low-commitment way to see exactly where a program stands before filing.

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Early-stage biotech

A credible FDA path for pre-seed to Series A teams, scoped to one lead program, with expert review and eCTD-ready output.

Enterprise & retainers

Project-based engagements or ongoing retainers for teams with continuous submission and gap-analysis needs.

See your gaps before FDA does.

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

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Louis Lalas, Founder & CEO, Amia.ai