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, [...]
01 The Best eCTD Viewing System to End Review Anxiety Are You Suffering from eCTD Review Fatigue? If your Regulatory Affairs team feels a constant knot of anxiety when facing a final submission, you're not alone. That sinking feeling—the result of slow software, cluttered interfaces, and the fear of a missed hyperlink—is what we call [...]
Translating Strategic Goals into Operational Excellence Strategic Pillar (Goal) Key Challenge Cited in Workshop DnxtSolutions Value Proposition Operational Scalability No systematic approach to answer agency questions (RTQ Management). Implement Robust RTQ Infrastructure: Define workflows, triage, and response standards to ensure timely approval and a robust, scalable process. Data as a Strategic Asset Data fidelity issues and [...]
The Tech Tsunami in Regulatory Ops: Are You Riding the Wave or Getting Swept Away? The world of regulatory operations is undergoing a massive transformation. We're talking about evolving tech, processes that actually talk to each other, and job roles that look nothing like they did five years ago. For anyone in life sciences, this shift [...]
Defining future & space. In the contemporary digital regulatory landscape, operational efficiency is a critical prerequisite for success. Regulatory publishing teams face an ever-increasing mandate: producing high-quality, eCTD-compliant submissions faster, with unwavering consistency, and under intense scrutiny. A significant and often underestimated challenge slowing these efforts remains the laborious task of hyperlink creation and maintenance. [...]
While climate change threatens their future, science shows that corals can adapt and survive if we keep them healthy.
Top 10 Reasons to go with our eCTD (Electronic Common Technical Document) solution. Several important factors come into play. The relative importance of these factors can vary depending on the specific needs and priorities of our customers, but here are some of the most crucial aspects to consider DnXT’s solution: Compliance with Regulatory Standards: We […]
Importance of a well built eCTD Reviewer The Best eCTD Viewing System to End Review Anxiety Are You Suffering from eCTD Review Fatigue? If your Regulatory Affairs team feels a constant knot of anxiety when facing a final submission, you're not alone. That sinking feeling—the result of slow software, cluttered interfaces, and the fear [...]
I DnXT: Redefining How Regulatory Operations Embrace Modern Technology The regulatory world is evolving quickly.New compliance requirements, faster approval timelines, and the growing complexity of data are forcing organizations to rethink how they operate. At the same time, technology has never been more capable of transforming those operations — if used the right way. That’s [...]
