The regulatory technology landscape in life sciences has, over the last five years, quietly transformed from a back-office category dominated by document repositories and submission publishing tools to one of the most consequential software segments serving the pharmaceutical, biotech, and medical device industries. Japan's regulator moved first, and most of the market wasn't ready for what that meant. Japan's Pharmaceuticals and Medical Devices Agency (PMDA) made eCTD 4.0 mandatory from April 2026, well ahead of Europe (foreseen around 2027) and years ahead of the US, where there still isn't a firm date. That kind of regulatory pressure is exactly where the gap between what a vendor claims and what it's built starts to show. More recently, AI and agentic capabilities are entering these platforms, though maturity varies widely between vendors and much of what is promoted remains at an early stage.

The main goal is continuous improvement.
Through the Frost Radar™ you will find answers for the following:

• Why are connected regulatory information management platforms becoming central to modernizing regulatory operations through integrated data, workflows, and intelligence?
• What role do tech-enabled services play in helping pharmaceutical, biotech, and generics companies plan, prepare, submit, track, and maintain regulatory filings with health authorities?
• What are the major companies benchmarked in this Frost Radar™, and how can you adopt industry strategies and gain a competitive edge over them?