Most of a submission is assembly and consistency checking
CTD sections, clinical study reports, protocols and investigator's brochures draw on the same sources again and again. Writers spend hours finding the current approved version, carrying numbers across documents and checking that sections agree. That's where inconsistencies slip through.
- The same data point appears in many documents and has to match everywhere
- Writers hunt for the current approved source
- Cross-references and consistency checks are done by eye
What we build
Source-grounded drafting
Drafts sections from the approved sources you specify, with every statement linked to its origin, for a writer to edit and own.
Consistency checking
Flags values, statements and terms that differ across documents, such as a sample size or dose that changes between sections.
Reviewer comment tracking
Collects reviewer comments in one place, links them to the text, and tracks what's resolved.
Source document search
Finds the current approved version of a source document, and the relevant passages, across your repositories.
How it works
Step 1: Define intended use
With your regulatory and QA leads, we document what the tool will and won't do. That's the basis for any validation your QA team performs.
Step 2: Connect approved sources only
The tool reads only from sources you designate, with least-privilege access. No open web, no unapproved drafts.
Step 3: Draft with citations, review by a person
Every draft shows its sources. A qualified reviewer edits, approves or rejects it before it moves toward a submission.
Step 4: Log every step
The audit trail records sources, AI output, human edits, reviewer and timestamp, so your team can show how a document was produced.
Systems we connect
These are capabilities, not shipped connectors. We scope each one during Discovery.
- SharePoint, Microsoft 365 and Google Workspace document libraries
- Regulatory information management (RIM) and eTMF platforms
- Private or self-hosted model environments for sensitive content
Reference
Our VP of AI Engineering, Michael Fethe, spent 15 years inside publicly traded agriculture and life science corporations. We bring that experience together with the documentation, audit-trail and private-deployment patterns we've built for regulated manufacturing and finance clients.
Related work outside life science: our EU Declaration of Conformity generator builds regulated documents from structured source data and logs every output. That's the pattern we'd apply here.
Questions regulatory teams ask
Will the AI write our submission?
No. It helps writers assemble and check content from approved sources. Your qualified people write, review, approve and own everything in a submission.
Is the tool 21 CFR Part 11 compliant?
Part 11 compliance depends on how a system is validated, controlled and used in your quality system, so no vendor can claim it alone. We design for audit trails, access controls and human review. Your QA team owns validation.
How do you keep the AI from making things up?
It drafts only from sources you designate and cites every statement. A reviewer checks each draft against those sources.