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, [...]
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. [...]
