DnXT is a cloud-native regulatory platform built on Azure, purpose-engineered for life sciences teams. From first submission to post-market maintenance, manage your entire eCTD lifecycle—publishing, review, compliance tracking, and health authority correspondence—in one place.
One Platform. Every Regulatory Milestone.
DnXT Platform
Enterprise Architecture
Java 21 backend, modular microservices, platform-independent. Deploys on your cloud or ours.
Modern UX
Fast, responsive interface designed by regulatory professionals for regulatory professionals. Works seamlessly across desktop and tablet.
Built-in AI
Intelligent document classification, automated hyperlinking, predictive validation, and natural language search across your submission archive.
Seamless Integration
Connects to Veeva Vault, SharePoint, and all major DMS platforms out of the box—no custom development required.
Scales With You
From a 5-person startup filing its first IND to a global pharma managing hundreds of sequences—DnXT adapts to your volume.
Enterprise Security
Enterprise-grade security, compliance with 21 CFR Part 11, and complete audit trails for every action.
01
DnXT RIM Suite
Your entire regulatory information management operation in one platform. Track registrations, manage submission plans, monitor health authority correspondence, and maintain a single source of truth across every market you operate in. Designed to collapse the time from last clinical trial to first submission—our target: under two weeks.
02
DnXT Publisher
Assemble and validate eCTD submissions with confidence. DnXT Publisher automates hyperlink generation, PDF rendering, and real-time validation against FDA, EMA, Health Canada, and TGA standards. Integrates directly with your DMS—pull documents, build sequences, and publish submission-ready packages without leaving the platform.
03
DnXT Reviewer
Navigate complex eCTD submissions in seconds. Compare sequences side by side, annotate with your team, track lifecycle changes, and validate compliance—all within a unified browser-based viewer. Built for collaboration between sponsors and CROs with complete audit trails.
04
Integrated AI
Intelligence woven into every workflow. DnXT AI automatically classifies documents, detects metadata errors before submission, summarizes regulatory correspondence, and flags compliance risks in real time. Not a bolt-on—AI is native to the platform and learns from your submission history.
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.
