Submission Readiness Sprint · 2-4 weeks
DSRV reads your CMC, quality, stability, and FDA-response materials the way a reviewer will, then hands your team a prioritized, human-reviewed gap map with an owner and a next action on every line.
AI helps draft and map. Humans review, interpret, and decide.
Why sprints start
The justification for critical quality decisions lives across old decks, email threads, and a folder named final-final. Nobody can point to the version that counts.
The charts exist. What is missing is the line from each chart to the claim it is supposed to support, and where that support runs thin.
Promises made in past correspondence sit in shared drives with no owner, no status, and no next action attached to any of them.
Where the platform is headed
The sprint runs on the same rails the platform is being built around: a public front door, a controlled portal for documents, and a human review gate before anything reaches your team.
Labeled honestly: public intake and the controlled document portal are live today, every review runs through humans, and a formal validation path is roadmap direction, not a current claim.
The sprint, step by step
Product type, pathway, evidence volume, and current FDA context, through the public intake form.
CMC, quality, stability, and response materials mapped to claims and requirements, sources preserved.
Missing, weak, and contradictory evidence separated from cosmetic cleanup and written into gap notes.
Every gap gets a name and a next action, so nothing sits in a shared drive without one.
The matrix, registers, and review notes assembled into a packet built for your team to act on.
DSRV reviewers and your quality unit interpret the findings. People decide; the packet supports them.
Sprint deliverables
Eight review-ready artifacts: source-grounded, owner-aware, and clear about what is known, what is weak, and what needs a human decision.
Claims against evidence, with the support level for every lane.
Question lanes with owner, status, and next action attached.
Where trend data supports the claim, and where it does not.
Analytical method changes with bridge rationale drafted for review.
Prioritized CMC risks, each with a severity and an owner.
The decisions your quality unit must make, framed for review.
Every document fingerprinted, versioned, and traceable to its source.
What was delivered, who reviewed it, and what was accepted.
The human boundary
AI-assisted content is draft support until a human reviews it. DSRV does not make regulatory decisions for you, and the sponsor remains responsible for final quality and regulatory calls.
Controls today, direction tomorrow
Every intake, upload, and review action lands on an event history that cannot be edited after the fact.
Documents are SHA-256 fingerprinted and byte-verified in transfer, so evidence stays traceable to its source.
Client documents move through a controlled portal with scoped access, never through the public site.
Reports move draft to released only through re-authenticated human sign-off, and lock after release.
Passkey and PKI-backed signatures for approvals are on the roadmap, beyond today's attested sign-offs.
DSRV is building toward GxP-aligned, human-in-the-loop workflows with a formal validation evidence path.
Roadmap items describe direction, not a validation claim. DSRV is at a governed, pre-validation stage and says so.
Start with a focused readiness call: product type, current evidence, likely risk areas, and whether a sprint is the right next step.