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See the trace

Every sentence traces back to its source.

Indago drafts only from your own regulatory documents. Follow any line the whole way down: the assertion it rests on, the source passage it was extracted from, and the exact sentence highlighted in your source documents. Nothing is asserted that your data doesn't support.

Notebook · provenance CTD 2.6.6 · live trace

Drafted prose

The no-observed-adverse-effect level (NOAEL) was 100 mg/kg/day in the pivotal 13-week oral rat study. No test-article-related mortality occurred at any dose level. Adverse findings at the high dose were limited to reversible hepatocellular hypertrophy. Repeat-dose effects fully reversed following a 4-week recovery period. Systemic exposure increased in an approximately dose-proportional manner. An exposure margin of roughly 10-fold relative to the projected clinical dose was maintained. High-dose hepatic changes correlated with adaptive enzyme induction rather than degeneration. The standard genotoxicity battery returned negative across all assays. No test-article-related effects were observed on reproductive organ weights or histology. Hematology and clinical chemistry parameters remained within the concurrent control range at all timepoints. Ophthalmic and electrocardiographic evaluations were unremarkable throughout the dosing period. Organ-weight changes were confined to the liver and were consistent with the hepatic adaptation described above. The integrated nonclinical assessment supports the proposed first-in-human starting dose and a 13-week clinical dosing interval.

Resolves to

Assertionassertion-7f2a9c · NOAEL 100 mg/kg/day
Passagep.47 ¶3 · pivotal study
Assertionassertion-2a8f55 · No mortality
Passagep.44 ¶4 · survival data
Assertionassertion-c93d12 · Hepatocellular hypertrophy
Passagep.49 ¶2 · histopathology
Assertionassertion-b41e08 · Reversible at 4 wk
Passagep.52 ¶1 · recovery cohort
Assertionassertion-5d7e21 · Dose-proportional AUC
Passagep.51 ¶2 · toxicokinetics
Assertionassertion-9b3c84 · ~10× exposure margin
Passagep.53 ¶5 · margin calc
Assertionassertion-1e6a47 · Adaptive enzyme induction
Passagep.50 ¶2 · liver pathology
Assertionassertion-8c0f73 · Genotoxicity negative
Passagep.61 ¶1 · S2 battery
Assertionassertion-4f2d19 · No reproductive effects
Passagep.58 ¶3 · organ weights
Assertionassertion-3e9b07 · Clinical pathology unremarkable
Passagep.55 ¶2 · hematology & chemistry
Assertionassertion-a6c4f2 · Ophthalmology & ECG normal
Passagep.56 ¶1 · in-life evaluations
Assertionassertion-d18a35 · Organ-weight change liver-confined
Passagep.57 ¶4 · organ weights
Assertionassertion-72b9e0 · Starting-dose rationale
Passagep.63 ¶1 · integrated assessment

In your source

Tox-13wk-Rat.pdfp.47
¶3No‑observed‑adverse‑effect level (NOAEL) was established at 100 mg/kg/day in the 13‑week oral toxicity study.
Tox-13wk-Rat.pdfp.44
¶4No mortality attributable to the test article occurred in any treated group through terminal sacrifice.
Tox-13wk-Rat.pdfp.49
¶2Centrilobular hepatocellular hypertrophy at the high dose was minimal to mild and considered adaptive.
Tox-Recovery.pdfp.52
¶1Test‑article‑related findings reversed completely following the 4‑week recovery phase.
Tox-TK.pdfp.51
¶2Systemic exposure (AUC0–24) increased in an approximately dose‑proportional manner across groups.
Tox-Recovery.pdfp.53
¶5Exposure margins of approximately 10‑fold relative to the projected clinical AUC were maintained.
Tox-13wk-Rat.pdfp.50
¶2The change was associated with hepatic enzyme induction, consistent with an adaptive rather than degenerative response.
Genetox-Summary.pdfp.61
¶1All assays in the standard genotoxicity battery (Ames, chromosomal aberration, micronucleus) were negative.
Tox-13wk-Rat.pdfp.58
¶3No test‑article‑related effects on reproductive organ weights or histopathology were identified.
Tox-13wk-Rat.pdfp.55
¶2Hematology and clinical chemistry values remained within the concurrent control range at all timepoints.
Tox-13wk-Rat.pdfp.56
¶1Ophthalmic examinations and electrocardiographic evaluations were unremarkable throughout dosing.
Tox-13wk-Rat.pdfp.57
¶4Organ‑weight changes were confined to the liver and consistent with the adaptive hepatic response.
Tox-Overview.pdfp.63
¶1The integrated nonclinical assessment supports the proposed first‑in‑human starting dose and dosing interval.

Hover a sentence. Indago resolves it to assertion → source passage → the exact line in your source PDF.

The AI does the heavy lifting.
Your experts stay author of record.

Indago reads your source data, drafts each CTD section, and hands you a document that's fully controlled by your team. Every output is traceable. Every edit is versioned. The AI accelerates the work. Your experts remain the authors who sign off on it.

STEP 01

Sources in

Upload your study reports, dossiers, stability data, and lab documents. Indago reads every file and extracts every relevant passage with page and paragraph coordinates.

STEP 02

Assertions extracted

Atomic, verifiable statements are pulled from your source passages, each addressable by ID, traceable to source, and ready to power the draft.

STEP 03

Narrative drafted

Assertions are synthesized into CTD-structured prose, with gaps flagged in real time where your source data falls short.

STEP 04

You own the output

Edit directly in the Notebook. Every change is versioned and attributed. Export to a submission-ready, eCTD-compliant package, provenance intact.

The AI drafts. Your experts stay in control.

See the full product

Know the gaps in every section, before the FDA does.

As Indago drafts each section, it checks every assertion against your source data and the regulatory compliance standards required for submission. Gaps are flagged by section and by severity, with specific guidance on what's missing or unsupported. You see them while you're still in the document, not after you've submitted. Fix the holes before they become the FDA's response.

  • 01
    Severity-ranked, with the fix attached.

    Every gap is graded by severity and paired with the specific action that closes it, so your team works the blockers first, not a flat checklist.

  • 02
    Export the analysis as a working document.

    One click turns the live view into a shareable report in PDF, Excel, or CSV, in a section-centric or categorical-matrix layout. Each file is headed with the project, a timestamp, total gaps, and the breakdown by section.

  • 03
    A readiness baseline you can track to submission.

    Because every export is timestamped and counted, falling gap totals become a measurable distance to filing your team and advisors can hold to.

Gap analysis runs from your first uploaded study through every draft: missing studies, unsupported assertions, incomplete protocols, and compliance mismatches, surfaced at any stage of preparation.

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Instant Answers, Verifiable Citations

Ask in plain language, get a plain answer, every statement carrying a citation you can open and read in place. When the FDA returns a list of questions on your filing, paste them in and get a grounded response back.

  • Built for Health Authority Questions (HAQs). When FDA questions come back, draft each response against your own documents and ICH guidance, with citations reviewers can verify line by line.
  • Every answer cited. Each statement links to the page and paragraph, or guidance reference, it came from, viewable just like provenance.
  • Audit-ready answers. The same provenance chain applies: assertion to source passage to document. Your QA team can verify without asking you.

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Investors watching every milestone, and a regulatory team under pressure. Help your regulatory team reach a credible, defensible package faster, without losing time to manual assembly.

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Owning the science

You know the data cold. Indago turns your study reports into CTD-structured narrative you can defend line by line, without rebuilding the argument from scratch.

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Keep every assertion traceable per program and every source cleanly separated. Move faster across your roster without losing the thread on any one file.

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Doing more with less

Less manual assembly, fewer cycles lost to rework, more output from the team you already have.

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Compliance isn't just a checklist. It's a core capability. Indago delivers fully versioned, timestamped, and exportable audit trails designed to withstand the highest scrutiny from global reviewers.

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Ironclad security. Total data privacy. We treat security with the utmost urgency, removing every hurdle for your IT and legal teams. Your proprietary data and drafts are entirely isolated and protected. We never use your data to train our AI models. We keep our platform intelligent by training exclusively on evolving global regulatory updates, keeping you ahead of changing agency standards.

Try it on your own program.

Bring a real section. We'll show you the draft, the gaps, and the full trace back to source, on your data, in one conversation.

  • Walkthrough on your nonclinical or clinical source data
  • See gap detection and sentence-level traceability live
  • No prep required, around 30 minutes

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