10 Reasons Regulatory Teams Choose DnXT Over Legacy Platforms
Switching regulatory technology is never a casual decision. The stakes are high, the validation burden is real, and the cost of getting it wrong shows up in delayed submissions. So when regulatory teams make the move to DnXT, they do it for specific, defensible reasons — not because of a compelling demo, but because their current platform has become a constraint they can no longer work around.
Here are the ten reasons we hear most often.
1. Cloud-Native from Day One
DnXT was architected for the cloud from its first line of code. It runs on Microsoft Azure as a true multi-tenant SaaS platform — not a legacy desktop application rehosted on a virtual machine and called “cloud.” This means browser-based access from anywhere, zero-downtime updates delivered to all customers simultaneously, and an infrastructure that scales with your submission volume rather than requiring you to plan capacity in advance. For distributed regulatory teams — and nearly all of them are distributed now — this is no longer optional.
2. Purpose-Built for Regulatory, Not Adapted from Something Else
Some platforms started in clinical trial management and added a regulatory module. Others began as quality management systems and stretched into submissions. DnXT was built exclusively for regulatory operations. Every design decision, every data model, every workflow reflects how regulatory teams actually work — dossier planning, eCTD compilation, submission review, and regulatory information management. When your platform was designed for your function, you spend less time configuring it to behave the way you need and more time using it.
3. Deployment in Weeks, Not Months
Because DnXT is SaaS, deployment doesn’t involve server provisioning, network configuration, or months of IT coordination. New customers are typically operational within weeks. Validation packages — IQ, OQ, and PQ — are delivered as part of the onboarding process, not scoped as a separate professional services engagement. For a Senior Director who needs to be publishing eCTD sequences next quarter, not next year, this timeline difference is material.
4. Transparent Pricing Without Hidden Services Costs
Legacy regulatory platforms often carry a pricing structure where the license is only the beginning. Implementation services, validation consulting, integration projects, annual maintenance, and per-incident support charges accumulate into a total cost of ownership that can be two or three times the quoted license fee. DnXT offers transparent, subscription-based pricing. Validation packages are included. Updates are included. Support is included. You know what you’re paying before you sign, and that number doesn’t quietly grow.
5. Full eCTD Lifecycle in One Platform
Most organizations cobble together their eCTD lifecycle from multiple vendors — one tool for publishing, another for review (or no dedicated tool at all), spreadsheets for planning, and a separate RIM database for tracking. DnXT integrates publishing, review, planning, and regulatory information management on a single platform with a shared data layer. A submission plan created in the RIM Suite flows into publishing workflows. A published sequence is immediately available for review. There’s no export-import cycle, no reconciliation, and no data integrity gap between systems.
6. AI Integrated into Workflows, Not Bolted On
Every technology vendor is talking about AI. The difference is where and how it’s implemented. DnXT embeds AI capabilities directly into regulatory workflows — document analysis during review, validation checks during publishing, and intelligent assistance during planning. The AI operates on your regulatory data within the platform, not as a separate tool that requires you to export documents, upload them somewhere else, and interpret results out of context. Integration at the workflow level is what makes AI actually useful rather than merely impressive in a demo.
7. Veeva Vault and SharePoint Integration via Open APIs
DnXT exposes documented REST APIs that enable integration with document management systems like Veeva Vault and SharePoint. This isn’t a proprietary connector that requires vendor professional services to configure — it’s an open, standards-based integration layer that your IT team or integration partner can work with directly. Documents flow between systems. Metadata stays synchronized. And when Veeva or Microsoft updates their platform, the API-based integration adapts without requiring a custom patch from your regulatory software vendor.
8. 21 CFR Part 11 Compliant and Validated Out of the Box
Compliance with 21 CFR Part 11 isn’t a configuration option in DnXT — it’s embedded in the platform architecture. Audit trails, electronic signatures, access controls, and data integrity safeguards are built into every module. Validated IQ/OQ/PQ documentation is delivered as part of deployment, giving your quality assurance team what they need to complete qualification without extensive reverse-engineering or custom test scripting. For regulated environments, “validated out of the box” means months of effort removed from your implementation timeline.
9. Dedicated Support from People Who’ve Worked in Regulatory
When you call DnXT support, you reach people with regulatory operations experience — not a generalist help desk reading from a script. Our team brings over 30 years of combined domain expertise across eCTD publishing, global submission strategy, and health authority requirements. They understand why you’re calling, what’s at stake, and what “resolved” actually means in the context of a submission deadline. For a Senior Director whose team’s credibility depends on on-time, compliant submissions, the quality of support isn’t a nice-to-have — it’s a critical vendor evaluation criterion.
10. Built for Growing Biotech, Not Just Big Pharma
Many legacy platforms were designed for the largest pharmaceutical companies and then offered to smaller organizations as scaled-down versions — same complexity, fewer resources to manage it. DnXT was built with emerging and mid-size biotech companies in mind: organizations with 50 to 500 employees, lean regulatory teams, and a need for enterprise-grade capability without enterprise-grade overhead. The platform scales up as your pipeline grows, but it doesn’t require a dedicated IT department and a team of system administrators to operate from day one.
The Decision
Regulatory technology decisions are infrequent and consequential. The platform you select will shape your team’s efficiency, your submission quality, and your ability to scale operations as your pipeline advances. If your current tools are creating friction rather than removing it, that’s worth examining — carefully, but soon.
Contact our team for an honest conversation about whether DnXT fits your organization. We’ll tell you if it does — and we’ll tell you if it doesn’t.
