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.
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.
01
DnXT Publisher
Smarter, Faster eCTD Publishing
Transform complex dossier assembly into a streamlined, automated process. DnXT Publisher delivers compliant, submission-ready eCTD packages with real-time validation, automated metadata management, and direct DMS integration — so your team can focus on strategy, not formatting.
Automated Assembly
Drag-and-drop dossier building with intelligent document ordering and lifecycle management
DMS Integration
Seamless connection to Veeva Vault, SharePoint, and other document management systems
Real-Time Validation
Catch errors before submission with built-in eCTD validation against all regional specifications
Multi-Region Support
Publish to FDA, EMA, Health Canada, TGA, and more from a single platform
02
DnXT Reviewer
Redefining eCTD Review Excellence
Navigate complex eCTD submissions with an intuitive, cloud-native review experience. Compare sequences in seconds, collaborate securely across teams, and maintain complete audit trails — all within a single, unified platform built for regulatory professionals.
Lifecycle Tracking
Intelligent eCTD viewing with full lifecycle history and cross-reference navigation
Secure Collaboration
Annotation, comments, and review workflows with role-based access control
Sequence Comparison
Rapid side-by-side comparison of submission sequences with change highlighting
Labeling Comparison
Direct comparison of labeling content across previous lifecycles for faster QC
03
DnXT RIM Suite
Regulatory as a Strategic Capability
A comprehensive Regulatory Information Management suite that treats regulatory operations as a strategic asset, not administrative overhead. Plan submissions, track registrations, manage correspondence, and orchestrate your entire regulatory lifecycle from a single command center.
Submission Planning
Visual timeline management with milestone tracking, dependencies, and agency deadline monitoring
Correspondence Management
Centralized tracking of agency communications with automated response workflows
Registration Tracking
Global registration status dashboard with country-level visibility and renewal alerts
Marketplace Integration
Seamlessly connect with CROs, affiliates, and external partners for controlled outsourcing
04
DnXT AI
Intelligence That Understands Regulation
Purpose-built AI that seamlessly integrates into every stage of the regulatory lifecycle. From automated document classification and real-time validation to predictive compliance alerts and contextual review assistance — DnXT AI transforms manual effort into digital intelligence.
Document Classification
AI-driven tagging, metadata extraction, and automatic CTD section mapping
Compliance Prediction
Early alerts on regulatory changes, risk impacts, and potential submission gaps
Content Summarization
Contextual summaries of submission documents and sequence changes for faster review
Correspondence Analysis
Automated parsing and classification of agency correspondence with action item extraction
Strategy and Advisory
We work closely with your team to develop a tailored strategy for your goals. Our experts analyze your product and market to create a roadmap that optimizes timelines, resources, and compliance.
System Implementation
End-to-end deployment of Veeva Vault RIM, DnXT, or hybrid environments. Our consultants have delivered implementations for small biotechs and global pharma alike.
Custom Development
When off-the-shelf falls short, we build. Integrations, automations, and purpose-built tools that extend your platform capabilities.
Services
Expert Services. Proven Outcomes.
DnXT Services partners with regulatory teams to simplify complex processes, accelerate timelines, and fill capability gaps—so you can focus on your science. From strategy to system implementation to hands-on publishing, we bring deep domain expertise and a track record of delivery.
Our work isn’t just about creating - it’s about making a difference.
Let's make anImpact together
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.
OUR CLIENTS FEEDBACK
I am extremely grateful for the industry knowledge, support, and guidance our company received from DnXT Solutions for INCELL's first eCTD IND submission.
DnXT understood our needs, timelines and helped us leverage their tool in a matter of weeks, not months. We will continue to use DnXT Solutions, given their customer support and accuracy, for IND submissions as well as our Drug Master File submissions.
DnXT Publisher makes AdPromo Submission a breeze. It's integrated to Veeva PromoMats. They can generate the 2253 automatically and also create all of the m1 promotional material outline automatically.
Their Labeling comparison with previous lifecycles directly from the Viewer makes final QC so much faster.
DnXT helped us with business process transformation as we prepare for Registration globally. They were well versed with Veeva RIM Registration project. Instrumental in all of the Veeva connection projects.
Highly Recommend them for all your workshop needs. They know how to cater to all audiences.
Fantastic design, incredibly Support, and an absolute pleasure to use! We provide Publishing services and offer our customers DnXT Reviewer. They absolutely love using it.
DnXT Reviewer is one of the absolute best collaboration viewer between Sponsors and CROs. One of the best performing solutions out there.
Love it. Found it easy to get our Reviewer up and running. Amazing product! Amazing design, easy to find your submitted content! The support is also top quality, all the times I have asked for help, the help came and fixed my problems! 5/5
Thrilled to announce our new partnership with DnXT Solutions! We've successfully implemented their publishing tool, taking our eCTD submission capabilities to the next level. Our first submission is officially complete, and we're excited to continue collaborating with such an innovative, forward-thinking team
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.
