Platform

Cloud-Native Regulatory Platform

Publish Submissions in Days, Not Weeks

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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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.

Veeva Vault

Native integration with Vault RIM, PromoMats, and QualityDocs

SharePoint

Direct document pull and lifecycle sync with SharePoint DMS

Any DMS

Open REST APIs support integration with any document management system

Email & Notifications

Automated alerts, task assignments, and status notifications

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.

21 CFR Part 11

Full electronic signature support, comprehensive audit trails, and access controls that satisfy FDA requirements for electronic records.

Data Security

Azure-hosted with encryption at rest and in transit, SOC 2 aligned controls, and tenant-level data isolation for complete privacy.

Audit Trails

Every action is logged with user, timestamp, and change detail. Immutable records ensure full traceability for inspections and audits.

Role-Based Access

Granular permission controls ensure the right people see the right data. Configurable roles map to your organizational structure.

Validated Platform

IQ/OQ/PQ documentation packages available. Designed for CSV compliance with risk-based validation approach support.

Global Standards

Support for eCTD specifications across FDA, EMA, Health Canada, TGA, and more. Ready for eCTD 4.0 transition to HL7 FHIR-based standards.

Ready to Transform Your Regulatory Operations?
Let's get started

See how DnXT can streamline your submissions, accelerate reviews, and give your team back the time to focus on strategy.

Developing Next Generation Technology "A new Regulatory Platform" play_arrow DnXT Reviewer Fast and Comprehensive Validation play_arrow DnXT Publisher