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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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."
★★★★★
"The audit trail and compliance features made our FDA inspection seamless. Everything was documented and easily accessible."
★★★★★
"Multi-tenant architecture means each of our clients has complete data isolation. Security was a key factor in our decision."
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.
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.
Ready to Simplify Regulatory Operations?
Start with a consultation. Our regulatory experts will map your current workflow and show you exactly where DnXT fits.
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.
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.
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
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.
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.
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.
"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
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
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
72% 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
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.
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.
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.