Praxara
Regulatory submissions

From dossier chaos to submission-ready, with the audit trail on.

Upload a folder or ZIP, let Praxara auto-classify + nest into the eCTD tree, then use AI skills to extract, cross-reference, and gap-analyse each module before you ship.

Every IND, NDA, MAA, variation — one place.

A Praxara project holds your whole submission. Documents sort themselves into Module 1 (administrative), 2.3/2.4/2.5/2.7 (summaries), 3.2.S (drug substance), 3.2.P (drug product), 4 (nonclinical), 5 (clinical). The readiness dashboard turns green only when every required leaf section has a verified document behind it.

  • eCTD module structure enforced
    Module 1-5 tree matches ICH CTD format.
  • Auto-classification on upload
    60+ document types recognised from content, not filename.
  • Cross-reference checking
    Skill catches contradictions between Module 2.5 and Module 5 CSRs.
  • Gap analysis against requirements
    IND / eCTD Module 3 / MAA checklists built in. Custom sets supported.
  • Traffic-light readiness scorecard
    Per-module green / amber / red with missing-artefact list.
  • Every AI call audited
    Provider, model version, prompt hash, latency and token counts recorded per extraction — inspector-ready.

AI skills for regulatory affairs

regulatory-csr-extraction

Pulls study metadata, endpoints, population, results, adverse events, and stated limitations from a Clinical Study Report. Validates numeric values + flags unresolved ambiguity rather than fabricating.

cmc-analysis

Extracts Module 3.2.S / 3.2.P fields — drug substance identity, stability, manufacturing site, specifications, container/closure.

cross-reference-check

Compares structured extractions across documents. Flags every numeric or categorical disagreement between Modules 2 and 5.

gap-analysis

Runs your upload against a published requirement checklist (ICH eCTD Module 3, IND sections). Returns missing-leaf + recommendations.

A typical RA workflow

    1
    Create project

    Pick 'EU MAA' template or start blank. Set product, markets, target submission date.

    2
    Upload your dossier

    Drag a ZIP. Module paths detected from folder names. Azure DI extracts text + tables.

    3
    Run QC skills

    Gap analysis + cross-reference + CMC extraction. Reviewer approves findings.

    4
    Export

    Submission-ready package + a 21 CFR Part 11 audit trail for inspection.

See it against your own documents.

20-minute demo. Bring a redacted CSR, PSMF, or ICSR. We'll run it live end-to-end.

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