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.
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."
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.
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.