Dossier Gap Analysis: Objective, Scope, and US/EU Review Criteria for a Submission-Ready CTD Running a CTD Dossier Gap Analysis: Purpose, Boundaries, and Reviewer-Centric Criteria Why Perform a Dossier Gap Analysis: Triggers, Outcomes, and What “Good” Looks Like A dossier gap analysis is a structured, time-boxed review of draft CTD/eCTD content to identify what is missing, misaligned, or unverifiable before a formal submission or major supplement. Sponsors typically trigger it at key milestones—end of Phase 3 (to confirm evidence completeness), pre-NDA/BLA/ANDA (to lock narratives and anchors), or pre-variation (to confirm lifecycle coherence). The analysis is not a general editorial pass; it…