Articles tagged with “ich”

Learn eCTD publishing best practices for compliant regulatory submissions. This guide covers technical standards, validation, and requirements from FDA, EMA, an

Learn the FDA's mandatory eCTD submission requirements, including key deadlines, technical standards, and the transition from eCTD v3.2.2 to v4.0 for NDAs, BLAs

Learn what eCTD viewer software is and why it's critical for regulatory submissions. This guide covers key features, technical capabilities, and tools.

Learn about key clinical trial acronyms. This guide explains the definitions, history, and roles of GCP, ICH, IRB, EDC, and eTMF in clinical research.