Expert Consulting Meets Purpose-Built Technology
End-to-end submission management, regulatory content lifecycle, compliance-ready workflows — all in one validated, 21 CFR Part 11 compliant infrastructure.
"The only platform where your submission plan, documents, reviews, and publishing live in one connected system — no imports, no exports, no reconciliation."
End-to-End Submission Management
eCTD compilation, validation, and submission publishing for FDA, EMA, Health Canada, and 60+ global authorities. Supports eCTD 3.x and 4.0 (HL7 RPS) with automated cross-reference intelligence that eliminates manual hyperlink errors.
- eCTD 3.2.2, 3.3, and 4.0 (HL7 RPS) support
- Multi-regional publishing from a single dossier
- Automated cross-reference linking across modules
- Spec intelligence with pre-submission validation
- Submission lifecycle ops: new, replace, append, delete
- Grouped submissions (US application sets) and STF support
- 148+ validation criteria per region, benchmarked against industry validators
eCTD Review Built for How Agencies Read
Cumulative and current lifecycle views, native FDA form rendering, and AI-assisted review — a review environment built for real eCTD dossiers, with a complete audit trail behind every action.
- Cumulative and current views with full lifecycle resolution
- Native rendering of dynamic FDA (XFA) forms — 1571, 356h, 2253
- Large-file streaming and fast navigation across big dossiers
- AI document suggestions, version diff, and submission chronology
- Cross-dossier unified search
- Integrated with Publisher and EDMS
Planning and Regulatory Intelligence, Connected
Submission planning that understands eCTD structure — plus portfolio-aware regulatory intelligence, predictive health-authority question readiness, and correspondence tracking, all connected to document readiness and publishing.
- eCTD-aware plans and templates with global core + market variants
- Document-level tracking grid that replaces submission spreadsheets
- Portfolio-aware regulatory intelligence with live agency feeds
- Predictive HAQ readiness built from 1,000+ real health-authority questions
- Health-authority correspondence and commitment tracking
- Interactive Gantt timelines integrated with Reviewer and Publisher
Regulatory Content Lifecycle Platform
Enterprise document management with AI classification, compliance domains, and lifecycle governance. Built for regulated environments with 21 CFR Part 11 compliance from day one.
- AI-powered document classification
- 6 compliance domains: Regulatory, Quality, Clinical, Corporate, Commercial, Operations
- 21 CFR Part 11 e-signatures with cryptographic verification
- Training management: assignments, acknowledgments, compliance matrix
- Inspection readiness scoring with one-click audit packs
- Veeva Vault synchronization and full-text AI-enhanced search
Why DnXT
| Capability | DnXT | Legacy Tools | Veeva Vault RIM |
|---|---|---|---|
| Cloud-Native | ✓ Yes | ✗ Desktop/On-Prem | ✓ Yes |
| eCTD Publishing | ✓ Built-In | ○ Separate Tool | ○ Add-On Module |
| AI Cross-Reference Linking | ✓ Automated | ✗ Manual | ○ Limited |
| Integrated Planning | ✓ Planner | ✗ No | ○ Partial |
| Document Review | ✓ Reviewer | ✗ Separate Tool | ✓ Yes |
| Implementation Time | ✓ Weeks | ✗ Months | ✗ Months |
| Consulting Included | ✓ Yes | ✗ No | ✗ No |
See How It Works for Your Team
Our regulatory experts will walk you through the platform and show you exactly how it maps to your current workflow.
