Articles tagged with “common-technical-document”

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

Pharma Regulatory Submissions: Challenges & Digital Solutions

Explore key challenges in pharmaceutical regulatory submissions, from legacy eCTD issues and CMC gaps to the rise of AI and structured data for faster drug appr

35 min read

1/12/2026

regulatory submission ectd drug approval process regulatory affairs common technical document cmc ai in pharma fda ema