Submissions

Workflow Templates by Submission Type

Choose a structured workflow model for IND, NDA, BLA, ANDA, 510(k), and De Novo execution across authoring, publishing, validation, and remediation.

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IND

IND submission software for Module 1-3 drafting, clinical hold response planning, and cross-functional readiness tracking. Keep CMC, nonclinical, and clinical work aligned before filing.

Coordinate IND prep with structuredSurface Module 1 and Module

NDA

NDA submission software for supplement management, cross-functional readiness, and eCTD validation. Coordinate CMC, clinical, and labeling work so the package stays aligned through filing.

Align CMC, clinical, and RAReduce handoff bottlenecks with one

BLA

BLA submission software for CMC dependency tracking, evidence coordination, and review readiness. Keep clinical and manufacturing changes aligned as the package evolves.

Coordinate all BLA drafting andMap CMC and clinical dependencies

ANDA

ANDA submission software for bioequivalence tracking, labeling alignment, and deficiency-response routing. Keep repeatable workflows in place across product lines and GDUFA timelines.

Run repeatable ANDA readiness workflowsValidate bioequivalence and CMC evidence

510(k)

510(k) submission software for predicate mapping, evidence assembly, and submission readiness. Keep testing, labeling, and substantial-equivalence arguments aligned so review questions do not slow clearance.

Centralize predicate comparisons, testing evidence,Surface substantial-equivalence gaps earlier so

De Novo

De Novo submission software for evidence planning, risk-control traceability, and cross-functional execution. Coordinate novel-device arguments, testing, and clinical inputs so the classification request is easier to defend.

Keep device description, intended use,Track test results, clinical inputs,