Articles tagged with “regulatory-operations”

eCTD Submissions: A Guide to Management & Best Practices

Learn best practices for managing eCTD submissions. This guide covers the eCTD structure, publishing tools, QC processes, and how to avoid common technical erro

50 min read

1/14/2026

ectd submissions regulatory affairs ectd publishing common technical document ectd validation ectd 4.0 regulatory operations

CTD vs eCTD: Key Differences in Pharma Submissions Explained

Learn the key differences between the Common Technical Document (CTD) and electronic CTD (eCTD). This guide covers the evolution from paper to the XML-based eCT

35 min read

1/14/2026

ctd vs ectd regulatory affairs pharma submissions ich guidelines common technical document ectd format nees electronic submissions regulatory operations

The Evolution of eCTD Publishing to Unified Archives

Examines the evolution of eCTD systems from specialized publishers for regulatory submissions to enterprise platforms that serve as a unified drug lifecycle archive, including the impact of eCTD v4.0, AI-powered RIM tools, and IDMP compliance.

35 min read

8/13/2025

ectd regulatory submissions ectd publishing unified archive drug lifecycle management regulatory operations