We can now build enterprise systems in weeks, author millions of pages in minutes, and compare vast datasets in seconds. The days of filling forms, organizing documents in folder structures, and worrying about navigation and formatting are taking attention away from the original mission: providing the right information to the right people to ensure safety, compliance, and efficacy—so approvals or rejections can be made quickly and confidently.

Yet many current solutions are still building for ideas formed 10 years ago. Even eCTD 4.0 is essentially updating processes designed for a different era. We shouldn’t be optimizing yesterday’s workflows—we should be thinking about eCTD 20.0, where intelligence, automation, and collaboration drive regulatory excellence.

At DnXT Solutions, we help organizations meet unmet needs by building intelligent, AI-powered systems that put focus back on what matters most. Our solutions ensure that the right information reaches health authorities and that collaboration across teams and regions happens seamlessly. Administrative compliance is no longer the goal—strategic, insight-driven action is.

With modern low-code and AI tools, organizations can now turn regulatory complexity into clarity, enabling smarter decisions and faster approvals. The future of Regulatory Affairs is not just about managing documents—it’s about extracting intelligence, accelerating processes, and driving better outcomes.

Ready to transform your regulatory operations? Contact us at sa***@***********ns.com or visit www.dnxtsolutions.com/contacts to learn how we can help.