Let’s start with something most regulatory technology companies would never say out loud: we’re not the biggest player in this space. Not even close.
Veeva Vault RIM is the dominant platform in life sciences regulatory information management. EXTEDO has been a trusted name in eCTD publishing for over two decades. Lorenz docuBridge is a workhorse that regulatory teams across Europe rely on daily. These are serious companies with serious products, and we respect what they’ve built.
So why does DnXT Solutions exist?
Because we believe there’s a massive gap between what these platforms offer and what most life sciences companies actually need.
The $300K Problem
Here’s what happens when a growing biotech company — say, 50 to 200 people — decides it needs proper regulatory submission management. They start evaluating platforms. They sit through enterprise demos. They get quotes.
And then they see the numbers.
Enterprise RIM platforms routinely cost six figures annually before you even factor in implementation, validation, training, and the small army of consultants needed to get everything configured. Implementation timelines stretch to 12 or 18 months. By the time you’re live, you’ve spent more on your submission management tool than on some of your actual submissions.
For a company with three products in development and a lean regulatory team, that math doesn’t work.
Built Different, On Purpose
DnXT wasn’t built by stripping features out of an enterprise platform and calling it “lite.” We built our platform from the ground up for the companies that the enterprise vendors overlook — emerging biotech, specialty pharma, CROs, and regional affiliates who need compliant, capable tools without the overhead.
Here’s what that means in practice:
You get started in weeks, not quarters. Our cloud-native architecture on Azure means no lengthy on-premise installations, no server provisioning, no IT infrastructure projects. Your regulatory team can be reviewing eCTD submissions and planning dossiers within weeks of signing on.
You get a platform that evolves with you. We ship updates continuously. When the FDA updates its validation criteria or the EMA changes its submission requirements, we don’t wait for a quarterly release cycle. We respond, and you benefit immediately.
You get AI that actually works, not AI that’s bolted on. Every major RIM vendor now has an “AI strategy.” Most of them amount to adding a chatbot on top of a 15-year-old architecture. We built DnXT AI into the core of our platform — from intelligent document review to compliance analysis to submission template recommendations that learn from your organization’s history. It’s not a feature; it’s how the platform thinks.
You get pricing you can explain to your CFO. No complex module bundling. No surprise per-user tier jumps. We believe that regulatory compliance tools shouldn’t require a procurement project of their own.
What We’re Not
Transparency matters to us, so here’s what we won’t pretend to be:
We’re not the right fit for a top-20 pharma company managing 10,000 active registrations across 150 countries. If that’s you, Veeva or IQVIA are probably your best bet, and we’ll say that without hesitation.
We’re not a legacy vendor with 25 years of installation history. We’re newer, and we see that as an advantage — no technical debt, no architectural compromises made in the pre-cloud era.
We’re not trying to be everything to everyone. We’d rather be exceptional at eCTD publishing, regulatory review, and submission planning for the companies that need us most.
The Future We’re Building Toward
Our north star is ambitious and specific: reduce the time from last clinical trial to first regulatory submission to under two weeks.
That might sound aggressive. It is. But when you look at where the bottlenecks actually live — document assembly, cross-referencing, validation cycles, format compliance — these are fundamentally software problems. They’re problems that modern architecture, intelligent automation, and AI can compress dramatically.
The regulatory landscape is shifting. eCTD 4.0 is coming, bringing a fundamental architectural change to how submissions are structured. Health authorities are modernizing their systems. The companies that adapt fastest won’t be the ones with the biggest IT departments — they’ll be the ones with the most agile technology.
That’s the bet we’re making. And we’re building DnXT to prove it.
See It for Yourself
We don’t believe in 47-slide pitch decks or demo environments that look nothing like the real product. If you want to see what modern, affordable regulatory technology looks like, reach out. We’ll show you the actual platform, walk through your specific use case, and give you a straight answer on whether DnXT is the right fit.
Because sometimes the right answer isn’t the biggest name. It’s the right tool for the job.
DnXT Solutions provides cloud-based eCTD publishing, review, and regulatory planning tools for life sciences companies. Learn more at dnxtsolutions.com or contact us at sa***@***********ns.com.
