Why We Built DnXT: A Modern Platform for Regulatory Operations
If you lead regulatory operations at a pharma or biotech company, you already know the landscape. The tools your team relies on were architected in the mid-2000s, built on desktop-first assumptions, and held together with layers of customization that nobody fully understands anymore. They work — until they don’t. And when they don’t, the cost isn’t just frustration. It’s delayed submissions, audit findings, and operational drag that compounds quarter after quarter.
DnXT exists because we believed regulatory teams deserved better than patched-forward legacy software. Not a facelift on old architecture. Not another module bolted onto a platform designed for something else. A ground-up rebuild of the regulatory technology stack, designed for how teams actually work today.
The Problem with “Good Enough”
Most Senior Directors we talk to aren’t experiencing catastrophic system failures. Their pain is subtler and more pervasive. It’s the publishing team that can’t start work until a local install is updated. It’s the reviewer in a different time zone who needs VPN access and a specific desktop configuration just to open an eCTD sequence. It’s the submission planner still maintained in Excel because the RIM system is too rigid to reflect how regional strategies actually evolve.
These aren’t feature gaps. They’re architectural limitations. When a platform was built for on-premise deployment and single-user workflows, no amount of version upgrades will make it a modern, collaborative, cloud-native system. The bones are wrong.
Built from Scratch on Modern Infrastructure
DnXT runs on Microsoft Azure as a multi-tenant SaaS platform. That’s not a marketing distinction — it’s a fundamental architectural choice that changes what’s possible. Your team accesses the platform through a browser. There’s nothing to install, nothing to patch locally, and no dependency on a specific machine or network. When we ship an update, every customer gets it simultaneously, with zero downtime deployment.
The platform is built around open REST APIs, which means integration with systems like Veeva Vault and SharePoint isn’t a professional services project — it’s a configuration exercise. Data flows in and out through documented, versioned endpoints that your IT team can work with directly.
Four Products, One Platform
DnXT is not a single tool. It’s an integrated platform with four products that share a common data layer and user experience:
- DnXT Publisher — eCTD publishing and sequence compilation across FDA, EMA, Health Canada, TGA, and other regional formats.
- DnXT Reviewer — purpose-built eCTD review with annotation, role-based access, and AI-assisted analysis.
- DnXT RIM Suite — submission planning, dossier management, and regulatory information tracking.
- DnXT AI — intelligent capabilities embedded across the platform, from document analysis to submission validation.
The integration between these products is the point. When a submission plan is created in the RIM Suite, it flows directly into publishing. When a published sequence is ready for review, it appears in Reviewer with full structural context. There’s no export, no re-import, no reconciliation step where errors creep in.
Compliance as Architecture, Not Afterthought
DnXT is designed for 21 CFR Part 11 compliance from the infrastructure level up. Audit trails, electronic signatures, role-based access controls, and data integrity safeguards aren’t features we added to satisfy a checklist — they’re embedded in how the platform stores, transmits, and presents data. We deliver validated IQ/OQ/PQ packages so your quality team can complete qualification without reverse-engineering our system.
For regulated environments, this matters enormously. When compliance is architectural rather than bolted on, it doesn’t break when you update. It doesn’t require re-validation every time a new feature ships. It’s simply how the system works.
Proven in Production
DnXT is not a concept or an early-stage product. The platform has supported over 340 submissions published across more than 20 customers and 6 regional formats. These are real eCTD sequences accepted by real health authorities — FDA, EMA, Health Canada, TGA, Swissmedic, and MCC South Africa among them.
Our customers range from pre-commercial biotech companies filing their first IND to established specialty pharma organizations managing complex global dossiers. What they share is a conviction that their regulatory technology should accelerate their work, not constrain it.
The Strategic Question
If you’re a Senior Director evaluating your regulatory technology stack, the question isn’t whether your current tools can technically produce an eCTD sequence. Of course they can. The question is whether your current architecture supports the way your team needs to work over the next five to ten years. Distributed teams. Increasing submission volumes. Tighter timelines. Growing regulatory complexity across more regions. AI-assisted workflows that require clean, structured, accessible data.
Legacy platforms will continue to function. But functioning and enabling are different things. DnXT was built for the latter — to give regulatory operations teams a platform that matches the pace and complexity of modern drug development.
If that resonates, we’d welcome a conversation. Reach out to our team to see the platform firsthand.
