Planning, documents, publishing, review and quality on one platform built for life sciences, with AI you control. From IND to NDA, FDA to PMDA. Regulatory Submissions. Connected. 16 eCTD Regions 2.5K+ Validation criteria 20+ Life-sciences companies Request a Demo

Explore the Platform Yourself

Click through an interactive demo of DnXT Reviewer — see the dashboard, browse dossiers, search documents, and experience how regulatory teams work in DnXT.

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Enterprise-Grade Security & Compliance

GDPR
Compliant
GxP Validated
IQ/OQ/PQ

Integrates With Your Existing Tools

Box Egnyte Veeva SharePoint Azure AD Okta

20+
Customers
2,000+
Applications and dossiers submitted
16
eCTD regions
Part 11
Audit trail and e-signatures
Consulting + Technology

Regulatory Operations. Simplified.

Expert consulting + intelligent software for eCTD submissions, document management, and regulatory planning. Your submission plan, documents, reviews and publishing live in one connected record.

→ Talk to a Regulatory Expert See the Full Platform

Your regulatory expertise shouldn't leave when your consultant does.

DnXT keeps the plan, the documents, the decisions and the agency history in one record your team owns. What one person knows becomes what the organization knows.

One platform. Four products, one record.

No imports, no exports, no reconciliation. Everything connected from planning to gateway.

DnXT Planner

Submission planning and regulatory intelligence in one place: eCTD-aware plans, document-level tracking that replaces spreadsheets, portfolio-aware agency monitoring, predictive health-authority question readiness, and correspondence tracking.

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DnXT eDMS

Compliant document management beyond regulatory: Part 11 e-signatures with cryptographic verification, compliance domains across quality and clinical, training management, and inspection readiness with one-click audit packs.

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DnXT Publisher

eCTD compilation, validation, and submission publishing for FDA, EMA, Health Canada, and 16 eCTD regions. Supports 3.x and 4.0 (HL7 RPS), grouped submissions, deterministic auto-placement, and each region’s own validation criteria — over 2,500 in all.

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DnXT Reviewer

eCTD review built for how agencies read: cumulative and current lifecycle views, native FDA form (XFA) rendering, large-file streaming, cross-dossier search, and AI-assisted suggestions, version diff, and chronology.

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Modules

DnXT Labeling

CCDS compliance built into the document system: structural comparison of local labels against the Company Core Data Sheet, forced adjudication of every difference, per-market submission due dates driven by configurable change classes, and an artwork gate that will not open without an approved change control.

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Also available as modules on the same record: $1 and $1.

Consulting Services

We also work on the systems you already run.

Veeva Vault advisory across RIM and Quality — enablement and configuration, process consulting, training, and ongoing support — delivered by people who have repaired these systems, not just implemented them. Every engagement includes our Vault Knowledge System, and the Vault Health Check is a read-only assessment that surfaces the backlogs nobody is watching.

Built for Every Role in Regulatory

Whether you lead the team or manage the documents, DnXT solves your specific challenges.

VP / Head of Regulatory
Four tools for one submission
One platform. One team. Full visibility from planning to gateway. See every submission's status, every document's readiness, and every milestone — in real time.
✓ Planning, documents and publishing connected in one platform
Regulatory Operations / Project Managers
Plans that live in spreadsheets
DnXT Planner connects your timeline directly to document readiness and publishing milestones. Real-time dashboards replace status-update meetings.
✓ Real-time dashboards replace status-update meetings
Document Managers / QA
Version control and audit trails
Every document version, every review cycle, every signature — tracked and compliant. 21 CFR Part 11 compliant e-signatures and full audit history, end to end.
✓ 21 CFR Part 11 compliant e-signatures and full audit history
IT Decision Makers
On-premise tools that don't connect
Cloud-native platform with Veeva Vault integration, SSO, and API-first architecture. Each customer's data in its own database schema, encrypted at rest.
✓ No hardware. No servers to maintain. Onboarding run by people who publish submissions.

Why Regulatory Teams Choose DnXT

16 eCTD Regions
FDA, EMA, PMDA, Health Canada, TGA, SAHPRA, and more. Global coverage from day one.
AI Cross-Reference Linking
Proposes cross-module hyperlinks across eCTD modules; a publisher reviews and accepts each one.
Veeva Vault Bidirectional Sync
Documents flow between Vault and DnXT without manual export/import. True integration, not file transfers.
Spec Intelligence
Automatic validation against latest agency specifications before submission. Catch errors before the agency does.
Integrated Gantt Planning
Submission timelines connected to actual document and publishing status. No more spreadsheet guessing.
Part 11 E-Signatures
21 CFR Part 11 compliant electronic signatures and audit trails built into every workflow.
Multi-Tenant Architecture
Each client's data lives in its own database schema, encrypted at rest. Hosted on SOC 2 Type II certified Microsoft Azure.
No Hardware, No Upgrades
Cloud-native, no hardware, with onboarding run by our own regulatory team.

Ready to Simplify Regulatory Operations?

Start with a consultation. Our regulatory experts will map your current workflow and show you exactly where DnXT fits.