Application · Regulatory
Regulatory Atlas.
The regulatory workspace that authors and reviews every submission: CMC dossiers, market expansions, variations, health authority responses, labels and regulatory intelligence, in one governed place.
Regulatory Atlas was previously Dossier Atlas.
Long-term stability data through 36 monthsSTAB-36M · p.4 at 25°C ± 2°C / 60% RH ± 5% demonstrate no significant change in any critical quality attribute.
Assay at release was 99.2% of label claimCoA-117 · p.2, with all batches manufactured at commercial scale, 400 kgBMR-042 · p.13.
- ResolvedAcceptance criterion missing for impurity A
- ResolvedBatch table missing one commercial-scale lot
- ResolvedTerminology drifts from the 2.3 summary
Refine with AI
v7 · versioned · source links preserved through every edit.
What it does
One workspace for the entire regulatory authoring lifecycle.
- 01
Authors Module 2 and Module 3
Sections and QOS summaries drafted from your own BMRs, CoAs and stability data, every value tied to its source page.
- 02
Reviews the sources, then the draft
Source files checked before authoring begins, drafts checked before your team opens them, findings severity-graded and traceable to source.
- 03
Maps one dossier into each market
Module 1 and Part 1 content generated for the target market, gaps flagged, eCTD and ACTD handled.
- 04
Tracks variations across the portfolio
Post-approval variations authored and versioned, every submission audit-ready without a manual register.
- 05
Drafts health authority responses
Answers grounded in your own dossier and the correspondence your team has already sent.
- 06
Flags label divergence across markets
Label versions monitored, divergences surfaced and reviewed against source before they become findings.
- 07
Answers guideline questions with citations
Grounded answers on FDA and ICH guidance, plus an approval database and pathway research for upstream strategy.
All seven run on one knowledge base, one audit trail and one security model. The capability your team needs next inherits every one of them.
See it on your own dossier
Why teams trust the drafts
Speed only counts if the draft survives review.
- Fast01
Authoring as fast as CMC work demands.
Reads BMRs, CoAs, stability reports and analytical records, and returns structured Module 2 and Module 3 drafts within days.
ANDANDABLAINDacross the full CMC scope - Traceable02
Every value linked to its source.
Click a reference indicator and the originating record opens in split-screen. Every assay result, impurity threshold and stability conclusion is verifiable in seconds.
STAB-36M · p.4CoA-117 · p.2BMR-042 · p.13field-level lineage - Consistent03
Module 2 and Module 3, aligned automatically.
Every value, claim and term in the QOS links to its Module 3 section, and cross-module inconsistencies are flagged before your team opens the draft.
2.3 QOS ↔ 3.2.P2.3 QOS ↔ 3.2.Sno manual reconciliation pass - Reviewed04
Validation built into the authoring workflow.
Drafts checked against ICH Q-series guidelines, agency guidance (FDA, EMA, MHRA, PMDA and others) and pharmacopoeial requirements. Findings arrive as proposed corrections your team accepts or rejects.
CriticalMajorMinorseverity-graded findings
How it works
Most AI tools generate once and stop. Regulatory Atlas runs every step of the authoring workflow.
Every section moves through a six-step loop with an independent critique agent, and the draft is reviewed before your team ever opens it:
The document at this step
Reviewed against four sources of truth.
Guideline checks
Auto-crawled ICH, FDA and CFR requirements, kept current.
Refuse-to-receive
FDA completeness criteria, checked before submission.
Prior-query checks
Your own past health authority queries and deficiencies.
Custom checklists
Your company's SOP checks.
Custom Blueprints.
Every section's structure is a configurable blueprint: generated from guidelines or converted from a prior submission, granular down to dosage form and submission type. The baseline ships ready; your team configures and governs it.
Refine, governed.
Writers make targeted edits in natural language: convert content into tables, simplify language, tighten a description within CTD expectations. Every edit is versioned, and source links survive the change.
Proof points
What changed on the first draft.
Across pilot deployments preparing Module 3 sections and Module 2 QOS summaries for FDA and EU submissions.
- 80%
- faster to first draft
- 70–90%
- first-draft completeness
Measured in active deployments. Results vary by submission type.
Coverage
Built for the filings you actually make.
Regulatory Atlas covers the administrative and regional content (Module 1), the summaries (Module 2, QOS and clinical), the quality dossier (Module 3) and clinical documentation (Module 5) across ANDA, NDA and BLA submissions, in eCTD and ACTD.
Extending to a new submission type or market is configuration on the same platform, typically two to three weeks.
Integrations
Runs standalone. Integrates when you're ready.
Regulatory Atlas runs standalone: author, review, refine and export without touching your other systems, which is what makes a pilot easy to start. When you want integration, it's MCP-native, with version history and the audit trail preserved throughout.
Upstream connections (DMS, QMS, LIMS, EDC) and downstream ones (RIM, eCTD publishing) are built to fit your environment.
See Regulatory Atlas on your next submission.
A 30-minute walkthrough built around a section from your own dossier work. Pick the section that matters most to your team, and we'll run it live.
Runs in your infrastructure or ours, under the controls pharma requires. The full trust posture →