Freyr Solutions' expertise on the evolution of eCTD is featured in Pharma Focus Asia, with insights from Gouspasha Mohammed, Senior SME. The article explores the transition from eCTD 1.0 to 4.0, marking a significant shift in global regulatory submissions through automation, lifecycle management, and harmonization across regulated regions like the US, Europe, Japan, and Canada.

eCTD 4.0 introduces enhanced lifecycle tracking, metadata-driven validation, and interoperability with regulatory systems, ensuring faster approvals, efficient compliance, and reduced submission errors. The shift from traditional document-based processes to a standardized, structured submission format aligns global regulatory expectations, making digital transformation a necessity for life sciences companies.