KNOW YOUR REGULATOR · 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 in one trace. 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 trace, 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.
THE ARC
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.
WHAT IT PRODUCES
The document, and everything that has to travel with it.
A submission is not one artifact. It is a document, a set of claims, the evidence under each one, and a trail showing how they connect.
The submission itself
Drafted section by section against the structure the authority expects, with the source material already assembled rather than hunted for while writing.
A live trace matrix
Requirement to risk to evidence to the sentence that satisfies it, maintained as the draft changes rather than rebuilt from scratch before an audit.
The gaps, named
Where a claim is not yet supported by evidence you hold, stated as a delta with the specific evidence to generate, not discovered by a reviewer three weeks in.
WHY IT HOLDS
The audit trail is the work, not a reconstruction of it.
The expensive version of traceability is the one assembled afterwards, where somebody reads a finished document and works backwards to what justified each line. Doing it while the sentence is written costs almost nothing and produces a record that is actually true, because it was captured at the moment the decision was made rather than inferred from the result. For regulatory affairs, clinical, quality and product teams.
Ready to make traceability a byproduct?
Show us your submission. We will show you the trace underneath it.