Regulatory Submission Checklists
The most expensive submission failures are almost always avoidable: a stale safety update, a facility that was not inspection-ready, Module 2 summaries that drifted from the underlying data, or a technical validation error caught at the gateway instead of in-house. A disciplined readiness check before you file is the cheapest insurance against a refuse-to-file decision or a complete response letter.
These checklists are organized by submission type and by the review stage where each gap actually gets caught. Each one mirrors the criteria reviewers apply, from IND clearance through filing review, substantial-equivalence assessment, and the final eCTD technical validation. Run them as a gate, then use Assyro's automated gap analysis to verify the package against current FDA and ICH expectations before the review clock starts.
Readiness Checklists
A gate for every stage of the submission
Each checklist targets a specific review stage and the deficiencies that surface there, so a team can catch avoidable gaps while they are still cheap to fix instead of after the agency does.
IND-Enabling Readiness Checklist
Confirms the package that lets the FDA clear a 30-day review without a clinical hold: the GLP toxicology program is complete and the safety margin supports the proposed starting dose, the CMC section establishes identity, strength, quality, and purity, the investigator's brochure and protocol are aligned, and the general investigational plan is coherent. It flags the gaps that most often draw an information request before the study can start.
NDA / BLA Filing Readiness Checklist
Walks the dossier against the criteria the FDA uses during the 60-day filing review. It verifies the integrated summaries of safety and efficacy are present and traceable, that Module 2 overviews match the Module 4 and 5 datasets, that labeling drafts and the proprietary name request are in, that the safety update is current as of the submission date, and that every named manufacturing facility is inspection-ready. These are the items that most commonly trigger a refuse-to-file or a downstream complete response letter.
510(k) Substantial-Equivalence Checklist
Structures the substantial-equivalence argument the way the FDA reviews it: a valid predicate is identified, the indications for use match, the technological characteristics are compared and any differences are shown not to raise new questions of safety or effectiveness, and the performance testing (bench, biocompatibility, software, sterility) supports the claim. It also checks the eSTAR administrative completeness items that cause an early Refuse-to-Accept hold.
eCTD Validation Pre-Lock Checklist
The final technical pass before the sequence is locked and transmitted. It covers eCTD backbone validity, correct leaf and node placement against the ICH specification, lifecycle operators (new, replace, append, delete) applied correctly, hyperlink and bookmark integrity, PDF rendering and file naming compliance, and that no high-severity validation errors remain. Clearing this list is what prevents an avoidable technical rejection at the gateway.
Response & Resubmission Readiness Checklist
For when the agency has already responded. It confirms every deficiency in an information request, complete response letter, or 510(k) additional-information hold is mapped to an owner and an action, that each response cites the specific regulation and affected module, that cross-module consistency is re-verified after edits, and that the resubmission sequence is correctly structured so the response itself does not introduce new validation errors.
Turn the checklist into an automated gate
A manual checklist depends on someone remembering to run it. Assyro's gap analysis checks the actual package against current FDA and ICH requirements, surfaces the same readiness gaps automatically, and points to the exact module and regulation behind each one, so nothing slips through before submission.