Submissions
Choose a structured workflow model for IND, NDA, BLA, ANDA, 510(k), and De Novo execution across authoring, publishing, validation, and remediation.
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.
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.
BLA submission software for CMC dependency tracking, evidence coordination, and review readiness. Keep clinical and manufacturing changes aligned as the package evolves.
ANDA submission software for bioequivalence tracking, labeling alignment, and deficiency-response routing. Keep repeatable workflows in place across product lines and GDUFA timelines.
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.
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.
PMA submission software for Class III devices: organize clinical evidence, manufacturing information, and the substantial body of valid scientific evidence FDA expects, so a premarket approval stays coordinated through panel review and approval.