Readiness work, organized into six 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.
Submission Readiness Sprint
The 2–4 week productized sprint.
Evidence Gap Map, Risk Register, FDA Response Matrix, Roadmap. Best entry point.
Learn moreBiologics & 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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