The Regulatory Operations Partner

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.

→ Talk to a Regulatory Expert See How It Works

"The only platform where your submission plan, documents, reviews, and publishing live in one connected system — no imports, no exports, no reconciliation."

DnXT Publisher

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
  • 100% first-time acceptance rate
eCTD 4.0 Package — Ready
Validation — 23/23 Rules Passed
Cross-References — 147 Links Auto-Generated
FDA Gateway — Submitted
EMA CESP — Pending Review
DnXT Reviewer

Collaborative Document Review, Fully Compliant

Tracked changes, 21 CFR Part 11 compliant e-signatures, and structured approval workflows. Every version, every review cycle, every signature — tracked with a complete audit trail.

  • Tracked changes with side-by-side comparison
  • 21 CFR Part 11 compliant electronic signatures
  • Multi-level approval workflows
  • Real-time collaboration with role-based access
  • Complete audit trail for every action
  • Integrated with Publisher and EDMS
Document: Protocol Amendment v3.2
e-Signature: Dr. Smith — Approved
e-Signature: Dr. Chen — Pending
DnXT Planner

Submission Planning Connected to Reality

Regulatory submission planning with Gantt timelines, milestone tracking, and resource allocation. Your timeline connects directly to document readiness and publishing milestones — no more spreadsheet guessing.

  • Interactive Gantt timelines with dependencies
  • Milestone tracking linked to actual document status
  • Resource allocation across submissions
  • Real-time dashboards replace status meetings
  • Multi-submission portfolio view
  • Integrated with Reviewer and Publisher
NDA-2026-001 — Q3 Submission
72% Complete — Module 2.5 in Review
Module 1 — Complete
Module 3 — Complete
Module 2.5 — In Review
DnXT EDMS

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
  • Lifecycle governance with retention policies
  • Veeva Vault bidirectional synchronization
  • Full-text search with AI-enhanced discovery
  • Role-based access with complete audit trail
EDMS — Regulatory Domain
AI Classification: CTD Module 2.7 — 95% confidence
Vault Sync — Bidirectional Active
1,247 Documents — Fully Classified

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.

→ Start with a Consultation See Pricing