Are you ready to experience innovation at its finest? Discover our cutting-edge SaaS platform designed for Regulatory, powered by the latest technology and hosted securely on the robust Azure platform. Whether you’re head of Regulatory, an IT business partner, or simply someone who appreciates top-tier performance, our web app is designed to exceed your expectations. Every solution we deliver is guided by tailored frameworks and proven methodologies, ensuring alignment with each client’s unique goals—without compromising industry standards or technical excellence
Are you ready to experience innovation at its finest?
DNXT Platform
Core Philosophy & Client Alignment
Every solution delivered by DNXT is guided by tailored frameworks and proven methodologies. This ensures strict alignment with each client’s unique goals while maintaining industry standards and technical excellence. This client-first mindset positions DNXT as a trusted partner for organizations looking to innovate, scale, and lead in the digital era.
Enterprise-Grade Backend & Architecture
The backend is engineered for robust, enterprise-level operations: Enterprise-Grade Systems: Built to be platform-independent and deployment-ready. Cloud-Agnostic Infrastructure: Supports consistent results across diverse environments and business needs. Modular, Service-Oriented Architecture: This design choice accelerates delivery and enables flexibility, making it easier to integrate with third-party systems, scale independently, and respond quickly to market changes. This foundation supports the specific technical claims made earlier: it is a Java-based solution hosted securely on Microsoft Azure.
Modern Digital Experience (Frontend)
Our application boasts a modern design that enhances usability and captivates your audience.
DNXT is dedicated to designing modern, high-performance digital experiences that are:
Fast, secure, and engaging across all platforms.
Built with architecture choices that prioritize scalability, reliability, and adaptability for seamless performance in any environment.
Intelligent Capabilities
To truly unlock smarter operations, DNXT integrates intelligent technologies, including:
AI-driven automation
Predictive analytics
Natural language processing (NLP)
These integrations drive smarter decision-making, personalized experiences, and improved operational efficiency.
Scalability:
Whether you’re expecting a handful of users or your entire organization, our platform effortlessly scales to accommodate your needs, ensuring optimal performance at all times.
Seamless Integration
No cost integrations. Our system integrates with existing systems and processes, making adoption smooth and hassle-free. All DMS systems supported.
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 veresed with Veeva RIM Registration project. Instrumental in all of the Veeva connection projects.
Highly Recommend them for all your workshop needs. They now 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 Reivewer 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
We are passionate about innovation. We want to build efficient solutions together. Our motto is to grow together. We want to be your trusted partner in life science.
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.
Vault RIM Implementation
Our team assists in developing and managing a robust system implementation. We ensure that the right resources are assigned to tackle various activites. Our conultants have the know-how and experience to get you to your goals fast. We focus on engagment and value added activities.
CREATIVE VISIONARIES
Turning imagination into reality. We craft unique, inspiring solutions
Services
Building Trusted Partnership with Bold Execution
DNXT Services specializes in simplifying complex process to make any task more intuitive and easy to execute. We work closely with our clients to handle various aspects of the process, technology and high level objectives allowing clients to concentrate on their scientific innovations. The services provided by DNXT include Strategy & Advisory, End to End System Implementation, Program/Project Management, Business Process, Regulatory Publishing Services and Custom Software Development whether you need an integration or decide you need something better than what is available in the market.
Our work isn’t just about creating - it’s about making a difference.
Let's make anImpact together
01
DnXT RIM Suite
We believe Regulatory function to be a strategic capability of drug development as opposed to an administrative overhead. Our ambition is to shorten drug approval time from last clinical trial to first submission in under 2 weeks.
Our goal is to allow our customers to own a Regulatory SaaS system that seamlessly integrates with the marketplace (CROs, Affiliates). Flexibility to outsource parts of the regulatory operation by having total control of the end to end process. We have developed a platform that is intuitive, fast and just works.
02
DnXT Publisher
DnXT Publisher – Smarter, Faster eCTD Publishing
Take control of your regulatory submissions with DnXT Publisher, the intelligent eCTD publishing solution from DnXT Solutions. Purpose-built for life sciences, DnXT Publisher transforms complex dossier assembly into a streamlined, automated process — delivering compliant, submission-ready packages in record time.
With seamless integration to your DMS, real-time validation, and full support for global regulatory standards, your team can focus less on formatting and more on strategy. Whether you're submitting to the FDA, EMA, or beyond, DnXT Publisher helps you move faster, stay compliant, and scale with confidence.
Speed. Compliance. Simplicity. That’s the DnXT advantage.
03
DnXT Reviewer
DnXT Reviewer — Redefining eCTD Review Excellence
Experience faster, smarter, and more compliant regulatory reviews with DnXT Reviewer, the next-generation eCTD reviewing solution designed for global life sciences teams.
Built on innovation and precision, DnXT Reviewer transforms complex eCTD submissions into a seamless, intuitive review experience. Navigate submissions effortlessly, compare sequences in seconds, and collaborate securely — all within a single, unified platform.
With advanced lifecycle management, real-time validation, and AI-assisted insights, DnXT Reviewer empowers regulatory professionals to focus on what matters most — submission quality, speed, and compliance.
🔹 Key Highlights:
Intelligent eCTD viewing and lifecycle tracking
Rapid navigation with contextual cross-referencing
Secure annotation, collaboration, and audit trails
Built-in compliance with regional eCTD standards (US, EU, CA, etc.)
Cloud-ready architecture for scalability and remote access
DnXT Reviewer — your smarter path to regulatory review excellence.
04
Integrated AI
DnXT AI — Powering the Future of Intelligent Regulatory Operations
Meet DnXT AI, the intelligent core of next-generation regulatory transformation. Purpose-built for life sciences, DnXT AI seamlessly integrates advanced artificial intelligence into every stage of the regulatory lifecycle — from authoring and submission to review and compliance.
With DnXT AI, regulatory teams move beyond manual effort to true digital intelligence. The platform automates document classification, validates submissions in real time, predicts compliance risks, and even assists reviewers with contextual insights — all within one unified ecosystem.
🔹 Smarter Submissions: AI-driven document tagging, metadata validation, and error detection
🔹 Accelerated Reviews: Automated sequence comparisons and contextual content summarization
🔹 Predictive Compliance: Early alerts on regulatory changes and risk impacts
🔹 Seamless Integration: Works natively across the DnXT platform for end-to-end efficiency
DnXT AI isn’t just automation — it’s intelligence that understands regulation.
Transform your regulatory operations with a platform that learns, adapts, and empowers.
DnXT AI — Smarter. Faster. Compliant.