Two ways to get to a package that holds.

Submission Readiness Sprint

DSRV reads your CMC, quality, stability, and response materials the way a reviewer will, then hands your team a prioritized gap map with an owner and a next action on every line.

Quoted per sprint, scoped on a readiness call.

Best for

A team with scattered evidence and a decision to make, who needs experienced eyes on it before committing to a filing plan.

What runs automatically

• LiveEvidence mapped to a category and region checklist
• LiveCoverage tracked per requirement slot, so nothing sits unaccounted for
• LiveGap list drafted with the regulatory anchor behind each item

What a person always does

• DSRV reviewers interpret every gap, its severity, and its response lane
• Your quality unit makes the final regulatory decisions
• Every AI-assisted draft is reviewed by a person before it reaches you

What this does not do

• No approval prediction and no readiness score.
• DSRV does not stand in for your quality organization or regulatory affairs function.

Agentic Readiness Run

An agent does the assembly and the checking on your behalf: it bins every document into its requirement slot, verifies integrity, and keeps a cited running list of what is still missing. A qualified reviewer signs the readiness verdict.

Quoted per submission-ready package, per product and region.

Best for

A team filing the same product into more than one region, or running enough volume that the assembly work is the bottleneck rather than the judgement.

What runs automatically

• In buildDocuments binned into their requirement slots as they arrive
• LiveByte-level integrity check on every file, re-verified on download
• LiveRunning gap list with the regulatory anchor behind each item
• LiveAppend-only activity ledger, immutable at the database level
• LiveDocument receipt export for your own quality records
• In buildObjectively checkable items cleared automatically: slot filled, integrity verified, version current, not superseded
• In buildAccepted evidence carried across regions instead of re-uploaded
• In buildChase list drafted for the items still outstanding

What a person always does

• Every judgement item - whether the evidence actually answers the requirement - is dispositioned by a qualified reviewer
• The readiness verdict and the preflight sign-off are human, re-authenticated, and recorded
• Any review outcome or answer that reaches you is approved by a person, exactly as worded, before it is sent
• Automated notifications are limited to transactional confirmations from pre-approved templates and never carry a review judgement

What this does not do

• The agent never decides that your package is acceptable to a reviewer. It assembles and checks; a person judges.
• An acceptance recorded for one region does not transfer to another. The document carries across; the verdict is made again.
• Nothing on this platform transmits to a health authority. Filing remains your action, through your own channel.