01
Capture the situation
Client, product, pathway, timeline pressure, FDA interaction, and the specific submission friction point.
Starter workspace
Submission Intelligence starts before the upload button.
It starts with a structured intake: who the client is, what product they are preparing, what FDA-facing package is at risk, and what evidence already exists. That shared picture keeps the engagement disciplined before any document is exchanged.
02
Inventory the evidence
CMC sections, stability data, analytical validation, manufacturing records, FDA correspondence, SOPs, deviations, CAPA, OOS/OOT, and source files.
03
Map gaps to requirements
AI assists source coverage checks against FDA/ICH/CGMP anchors. Human DSRV review decides what matters and what is client-ready.
04
Deliver the action plan
Evidence Gap Map, FDA Response Matrix, CMC Risk Register, Filing Roadmap, and human-reviewed readiness report.
Core workspace objects
Client profileProduct profileSubmission requestEvidence inventoryRequirement mapGap findingsDeliverablesReview closeout
Ready?
Know what FDA will ask — before they ask it.
Start with a focused readiness review that maps your evidence, gaps, risks, and next steps. In a 30-minute call, we'll walk through your product type, current evidence, and the most likely FDA risk areas.