AUTHOR · SUBMISSIONS BUILDER
Every sentence traced to the rule behind it.
We turn unstructured documents into a structured, cited submission—where each claim maps to the exact regulation and the evidence that supports it. When the landscape shifts, the trace matrix updates itself instead of sending you back to the start.
THE METHOD
A submission that knows why every line is there.
Authoring and traceability are the same act, not two. As you write, the platform maps each decision to its regulation, risk, and evidence—so the audit trail is a byproduct of the work, not a scramble at the end.
Structured Authoring
We transform unstructured documents into structured data that maps to exact regulations and data-driven analyses—so drafting produces a machine-checkable record, not just prose.
End-to-End Traceability
User needs, requirements, risks, and tests link on one spine. We generate the trace matrix automatically and keep it live as the design evolves.
Human-Final Workflows
Automated drafting suggestions accelerate the work; the judgment calls stay with your experts. AI is a power tool here, never the autopilot.
eSTAR-Ready
Output flows into FDA's eSTAR structure, with every sentence-level decision and citation captured—so the submission is assembled, not reassembled.
WORKED EXAMPLE
One traceable spine, end to end.
A single claim, followed from the user need that motivates it to the regulation it satisfies. Change any link and the platform flags everything downstream—no silent gaps, no reduplicated review.
The trace matrix is generated, not typed—every requirement, risk, and test stays linked to its source, so a late design change surfaces exactly which sections need another look.
HOW IT WORKS
From scattered documents to a cited submission.
Structure first, so the audit trail comes for free.
Ingest & structure
Bring your existing documents; we extract the requirements, risks, and evidence into structured, linkable data.
Draft with guardrails
Suggestions map every claim to its regulation and evidence; your team makes the final calls.
Assemble & export
The trace matrix and eSTAR package assemble themselves from the structured record—audit-ready on demand.
Ready to make traceability a byproduct?
Show us your submission—we'll show you the spine underneath it.