The regulatory platform purpose-built for life sciences. AI-powered publishing, review, and compliance — from IND to NDA, FDA to EMA
Regulatory Submissions. Simplified
340+
Submissions Published
20+
Customers
4.9
User Rating
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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

SOC 2 Type II
Certified
21 CFR Part 11
Compliant
HIPAA
Compliant
GDPR
Compliant
GxP Validated
IQ/OQ/PQ

Integrates With Your Existing Tools

Box Egnyte Veeva SharePoint Azure AD Okta
★★★★★

"DNXT Publisher reduced our submission prep time by 70%. The automated validation catches errors we used to miss in manual review."

JR
Jennifer R.
Director of Regulatory Affairs
★★★★★

"The audit trail and compliance features made our FDA inspection seamless. Everything was documented and easily accessible."

MS
Michael S.
VP Quality Assurance
★★★★★

"Multi-tenant architecture means each of our clients has complete data isolation. Security was a key factor in our decision."

AK
Amanda K.
IT Director, CRO
4 Products
Publisher, Reviewer, Planner, EDMS
60+
Regulatory Authorities
100%
Cloud · No Hardware
Part 11
Validated Infrastructure
Consulting + Technology

Regulatory Operations. Simplified.

Expert consulting + intelligent software for eCTD submissions, document management, and regulatory planning. The only platform where your submission plan, documents, reviews, and publishing live in one connected system.

→ Talk to a Regulatory Expert See the Full Platform

One Integrated Platform. Four Powerful Products.

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

📦

DnXT Publisher

eCTD compilation, validation, and submission publishing for FDA, EMA, Health Canada, and 60+ global authorities. Supports 3.x and 4.0 (HL7 RPS) with automated cross-reference linking and spec intelligence.

🔍

DnXT Reviewer

Collaborative document review with tracked changes, 21 CFR Part 11 compliant e-signatures, and approval workflows. Every version, every review cycle, every signature — tracked and compliant.

📅

DnXT Planner

Regulatory submission planning with Gantt timelines, milestone tracking, and resource allocation. Your timeline connects directly to document readiness and publishing milestones.

📂

DnXT EDMS

Enterprise document management with AI classification, compliance domains, and lifecycle governance. Regulatory content lifecycle platform built for 21 CFR Part 11 compliance from day one.

Built for Every Role in Regulatory

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

VP / Head of Regulatory
"Tired of stitching together 4 different 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.
✓ Reduce submission cycle time by 40% with integrated workflows
Regulatory Operations / Project Managers
"Submission timelines slip because planning lives 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
"Manual version control and missing audit trails keep you up at night"
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
"Legacy on-premise tools are expensive to maintain and impossible to integrate"
Cloud-native platform with Veeva Vault integration, SSO, and API-first architecture. Multi-tenant with data isolation and encryption at every layer.
✓ Deploy in weeks, not months. No hardware. No maintenance burden.

Why Regulatory Teams Choose DnXT

🌐
60+ Regulatory Authorities
FDA, EMA, PMDA, Health Canada, TGA, SAHPRA, and more. Global coverage from day one.
🤖
AI Cross-Reference Linking
Automated intelligence that identifies and creates hyperlinks across eCTD modules. Eliminates manual hyperlink errors.
🔄
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 is isolated and encrypted. Enterprise-grade security with SOC 2 compliance.
⚡
Weeks, Not Months
Cloud-native deployment with expert onboarding. Go live faster than any legacy platform migration.

Ready to Simplify Regulatory Operations?

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


Cloud-Native Regulatory Platform

Publish Submissions in Days, Not Weeks

The only regulatory platform purpose-built for speed, compliance, and AI-powered review. From dossier assembly to agency submission — one unified ecosystem for your entire regulatory operation.

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SUBMISSIONS PUBLISHED
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CUSTOMERS WORLDWIDE
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USER RATING
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REGIONS SUPPORTED
Platform Architecture

Enterprise-Grade, Cloud-Native by Design

Built on Microsoft Azure with a modular, service-oriented architecture. Every component is designed for security, scalability, and seamless integration with your existing regulatory ecosystem. Our Java-based backend delivers platform-independent, deployment-ready operations while a modern frontend ensures fast, engaging experiences across all devices.

Azure Cloud Hosted

Secure, scalable cloud infrastructure with 99.9% uptime SLA. Multi-region deployment for global regulatory operations.

21 CFR Part 11

Full audit trails, electronic signatures, and role-based access controls that satisfy FDA requirements for electronic records.

Multi-Tenant SaaS

Isolated data with shared infrastructure efficiency. Each tenant’s data is fully separated with dedicated encryption keys.

Open REST APIs

Seamless third-party integration with documented REST APIs. Connect to Veeva Vault, SharePoint, and any document management system.

AI-Ready Infrastructure

Native NLP, document classification, and predictive analytics woven into the platform core — not bolted on as an afterthought.

Modern User Experience

Fast, responsive interface designed by regulatory professionals for regulatory professionals. Works seamlessly across desktop and tablet.

Seamless Integration

Works With Your Existing Stack

No-cost integrations. Connect DnXT to the systems you already use — adoption is smooth and hassle-free.

Veeva Vault

Native integration with Vault RIM, PromoMats, and QualityDocs

SharePoint

Direct document pull and lifecycle sync with SharePoint DMS

Any DMS

Open REST APIs support integration with any document management system

Email & Notifications

Automated alerts, task assignments, and status notifications

Built for Compliance

Regulatory-Grade Security & Standards

Every feature is built with life sciences compliance requirements at its core — not bolted on as an afterthought.

21 CFR Part 11

Full electronic signature support, comprehensive audit trails, and access controls that satisfy FDA requirements for electronic records.

Data Security

Azure-hosted with encryption at rest and in transit, SOC 2 aligned controls, and tenant-level data isolation for complete privacy.

Audit Trails

Every action is logged with user, timestamp, and change detail. Immutable records ensure full traceability for inspections and audits.

Role-Based Access

Granular permission controls ensure the right people see the right data. Configurable roles map to your organizational structure.

Validated Platform

IQ/OQ/PQ documentation packages available. Designed for CSV compliance with risk-based validation approach support.

Global Standards

Support for eCTD specifications across FDA, EMA, Health Canada, TGA, and more. Ready for eCTD 4.0 transition to HL7 FHIR-based standards.

Ready to Transform Your Regulatory Operations?
Let's get started

See how DnXT can streamline your submissions, accelerate reviews, and give your team back the time to focus on strategy.

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.

Try Interactive Demo
No signup required — click and explore instantly

Developing Next Generation Technology "A new Regulatory Platform" play_arrow DnXT Reviewer Fast and Comprehensive Validation play_arrow DnXT Publisher
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
WE ARE DnXT

ABOUT US

DnXT Solutions was founded on a simple conviction: regulatory operations should accelerate drug approvals, not slow them down. Our team combines deep regulatory domain expertise with modern software engineering to deliver a platform that regulatory professionals actually want to use. With 340+ submissions published and counting, we are a trusted partner for biotechs, CROs, and pharmaceutical companies navigating the complexities of global regulatory compliance.

eCTD 4.0 regulatory submission standards transition guide

CONTACTS

Let's work in your vision

 

We would be delighted to assist you! Whether you are seeking a demo, an evaluation, or simply want to learn more about how our regulatory publishing and strategy services can benefit your organization, please contact us for a complimentary consultation. We are committed to helping you navigate the regulatory landscape with confidence and efficiency.

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