Bring clarity to
your next submission.
A 2-4 week, human-led submission readiness sprint.
What does your
evidence support?
We organize what you have, highlight what is missing, and prepare for the questions ahead.
The sprint combines source-traceable evidence mapping, AI-assisted draft support and human review. Eight deliverables bring the evidence and its open questions into one conversation.
Explore how the sprint worksSee your evidence take shape.
A 56-second illustrated journey from six documents on your computer to a review packet, through section placement, initial AI drafts, reviewed feedback and corrections.
Read the walkthrough and document index
This silent film has visible captions. The examples are illustrative, not a universal submission checklist.
Your documents
Stability, manufacturing, packaging, C of A, method validation and risk assessment.
Upload
Upload all six fictional documents into your private DSRV Pharma workspace.
Organize
Customers select sections today. Proposed AI would suggest each placement.
Initial AI review
When enabled, AI drafts one specific comment per document for staff review.
Reviewed comments
A DSRV reviewer confirms the requests before customer-visible feedback.
Correct & re-upload
Make the requested corrections and re-upload v2. Human review follows.
Review packet
Prepare your review packet. Your team owns final decisions and authority filing.
Six documents, six requirement sections
Stability report
Section: Stability evidence.
Fictional initial draft: Add storage conditions.
Correction for review: Storage conditions added.
Manufacturing report
Section: Manufacturing.
Fictional initial draft: Identify batch and site.
Correction for review: Batch and site identified.
Packaging report
Section: Packaging.
Fictional initial draft: Link packaging configuration.
Correction for review: Packaging configuration linked.
Certificate of Analysis
Section: Specifications & quality.
Fictional initial draft: Include batch and release limits.
Correction for review: Batch and release limits included.
Method validation report
Section: Analytical methods.
Fictional initial draft: Add method acceptance criteria.
Correction for review: Method acceptance criteria added.
Risk assessment
Section: Risk management.
Fictional initial draft: Link risks to controls.
Correction for review: Risks linked to controls.
Inside your review dossier
Evidence Gap Matrix
Review detailClaims against evidence, with the support level for every lane.
FDA Response Readiness Map
Review detailQuestion lanes with owner, status, and next action attached.
Stability Support Review
Review detailWhere trend data supports the claim, and where it does not.
Method Bridge Notes
Review detailAnalytical method changes with bridge rationale drafted for review.
CMC Risk Register
Review detailPrioritized CMC risks, each with a severity and an owner.
Quality Unit Decision Packet
Review detailThe decisions your quality unit must make, framed for review.
Source Index / Evidence Inventory
Review detailEvery document fingerprinted, versioned, and traceable to its source.
Closeout Record
Review detailWhat was delivered, who reviewed it, and what was accepted.
AI helps prepare.
Humans decide.
AI-assisted drafts support the review. Human reviewers and the sponsor retain final decisions. A readiness sprint is preparation for those decisions.
Understand the service boundary