Flagship
Submission Readiness Sprint
The 2-4 week productized sprint.
Evidence Gap Map, Risk Register, FDA Response Matrix, Roadmap. Best entry point.
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Readiness work, organized into six lanes.
Every lane runs on the same backbone: source-traceable evidence, AI-assisted mapping, and human review before anything reaches your team.
Service lanes
Six lanes. One readiness system.
Each lane shares the same source-traceable evidence backbone. Start with the Sprint, then continue into the work that matters most for your submission.
Biologics & BLA Readiness
Aligning the regulatory story.
BLA readiness review, CMC organization, analytical method review, viral safety evidence review, comparability and stability package review.
Learn moreCombination & Diagnostic Readiness
Cross-Center coordination.
Antibody-marker programs, companion diagnostics, and combination products navigating CDER / CBER / CDRH coordination under 21 CFR Part 3.
Learn moreAI-Assisted Evidence Review
Source-traceable mapping.
Embedded across all engagements. Available stand-alone for teams already mid-submission who need a defensible second look.
Learn moreFDA Response & Deficiency Support
Organizing the response package.
FDA comment breakdown, response matrix, evidence ownership, and response package readiness for IRs, deficiency letters, and CRLs.
Learn moreInspection & Commercialization Readiness
From approval to launch.
Pre-approval inspection prep, GMP documentation review, batch record / deviation / CAPA review. Bridges to dsrv.io for ongoing inspection programs.
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