Six deliverables. One coherent picture.
No abstract dashboards. No promises of approval. Concrete artifacts your team can act on.
Evidence Gap Map
A visual mapping of your scientific, manufacturing, analytical, clinical, and FDA-correspondence materials against expected submission sections.
Submission Risk Register
Filing-blocking risks ranked by severity and FDA visibility, with mitigation paths and owners.
FDA Response Matrix
For Information Requests or deficiency letters: a question-by-question matrix of who responds, what evidence is needed, and what's still missing.
CMC / Method / Manufacturing Risk Register
Specific risks across chemistry, manufacturing, and controls — including method validation, batch records, and process consistency.
Inspection Readiness Watchouts
Pre-approval inspection risks identified from your evidence — before an inspector finds them.
Filing Roadmap
Prioritized action plan and timeline showing what to fix first, what to fix next, and what to file with.
Four weeks. No surprises.
A defined cadence with clear handoffs. You always know what we're doing and why.
Source & Inventory
Kickoff call, NDA, secure data exchange. We inventory every piece of scientific, quality, manufacturing, analytical, clinical, and FDA-correspondence material in your possession.
AI-Assisted Mapping
Our AI-assisted workflow extracts requirements from relevant FDA guidance, 21 CFR sections, and ICH guidelines, then maps your evidence against expected submission sections. Source traceability preserved.
Gap & Risk Identification
Human regulatory and quality professionals review every flag, gap, and risk. Critical-path risks separated from cosmetic ones. FDA pattern-matching surfaces known rejection themes.
Report & Roadmap
Submission Readiness Report delivered. Final readout call walks through every deliverable, the prioritized action plan, and the filing roadmap.
Bring what you have. We'll work with it.
You don't need a perfect data room. The Sprint works with what's there — and the Evidence Gap Map will tell us what isn't.
- Product type and intended pathway (or working hypothesis)
- Current FDA correspondence (IRs, meeting minutes, CRLs, hold letters)
- Analytical method documentation (verification / validation reports)
- Manufacturing batch records, deviations, CAPAs
- Process and method validation reports
- Stability data
- Nonclinical and clinical study reports (where applicable)
- Labeling drafts
- Any prior pre-submission FDA feedback
Common questions. Real answers.
We don't write your submission. We assess whether your submission can be written defensibly with the evidence you have, and what's missing if not.