Sutra · For life science and pharmaceutical industries
Sutra Regulatory
Find the gaps before the agency does.
Interactive demo
Try it, then decide.
Check submission readiness, surface a cross-document gap, and draft the response.
Sutra Regulatory — interactive preview
Try it
Preview
Step 1 of 4
What is happening
Submission readiness for FDA is tracked across every CTD module
Sutra Regulatory · Submission readiness
NDA 1239 · Updated 12s ago
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Overall readiness
78
/ 100
+3 since last week
Module 192
Module 281
Module 373
Module 474
Module 586
Advance to surface open gaps and next actions
Why teams choose it
Three things it changes.
01
Submission readiness
Cross-document gaps and inconsistencies surface before a filing goes out.
02
Grounded response drafts
Health-authority questions get first-draft answers with citations for the reviewer.
03
Audit-ready trail
Every AI-assisted output is traceable to source and reviewer sign-off.
How it runs
Four steps. That's the whole loop.
- Submission assembledModules · sections · appendices
- Sutra checks readinessGaps & inconsistencies
- Response draftedGrounded in the dossier
- Reviewer approvesAudit-ready trail
Details
Discovery call
See Sutra Regulatory on your workflow.
30 minutes. No slides.