Client and urgency
Company / team / rolePrimary contactConfidentiality expectationsTarget date or decision pressure
Submission sprint intake
Tell us what is missing before FDA does.
Start with a structured readiness intake. We use the first pass to understand the product, submission pathway, available evidence, FDA pressure, and the deliverable your team needs.
AI assists evidence mapping and source coverage checks.
Human DSRV quality/regulatory review controls interpretation.
No approval guarantees, no replacement of sponsor responsibility.
Intake blueprint
What DSRV needs first
Product profile
Product type or modalityDosage form / device / diagnostic contextDevelopment or commercial stageManufacturing and site context
Submission request
IND / IDE / NDA / ANDA / BLA / supplement / 510(k) / De Novo / IR / CRLCurrent FDA interaction statusSpecific stuck point or review riskDesired sprint deliverable
Evidence available
FDA correspondenceCMC or quality sectionsStability dataAnalytical validation / method lifecycle recordsManufacturing records, deviations, CAPA, OOS/OOT, SOPs
Nothing here asks for source documents. DSRV confirms confidentiality and sets up controlled, engagement-private intake before any file is requested.
Structured readiness intake
Submit the readiness context DSRV needs to triage fit.
This creates a structured review record for DSRV. Keep source documents out of this form; controlled evidence intake comes after confidentiality and scope are confirmed.