Compliance & Submission Resources
Enterprise-grade compliance resources for NAMs regulatory submissions across FDA, EMA, and global agencies.
Submission Resources
NAMs Submission Guides
Step-by-step guidance for including NAMs data in regulatory submissions worldwide.
NAMs Submission Guide
Comprehensive guidance for including NAMs data in IND, NDA, BLA, and MAA regulatory submissions across agencies.
Validation Checklists
Comprehensive validation checklists for organ-on-chip, organoid, and computational model qualification.
Data Standards
SEND, CDISC, and emerging NAMs-specific data standards for regulatory submission formatting.
GLP/GxP Requirements
Good Laboratory Practice requirements for NAMs studies intended for regulatory submission.
Sample NAMs Submission Checklist
Define clear Context of Use (COU) aligned with specific regulatory question
Document assay/model validation with fit-for-purpose performance data
Include comparison to traditional methods or historical data where available
Provide GLP compliance documentation or scientific justification for non-GLP
Format data according to SEND/CDISC standards for electronic submission
Request pre-submission meeting to discuss NAMs strategy with agency