Articles tagged with “hl7-rps”

A Guide to the ICH M8 eCTD v4.0 Submission Specification

Learn about the ICH M8 eCTD v4.0 submission specification. This guide covers its technical basis in HL7 RPS, file requirements, and global adoption timelines.

40 min read

1/15/2026

ich m8 ectd v4.0 hl7 rps regulatory submissions submission specification regulatory affairs ectd pharmaceutical regulation

eCTD Publishing Software: An In-Depth Guide for v4.0

A technical guide to eCTD publishing software for regulatory submissions. Compare top tools like LORENZ, EXTEDO, and Veeva for eCTD v4.0 compliance and validati

30 min read

1/12/2026

ectd publishing software ectd v4.0 regulatory submissions submission validation lorenz docubridge veeva vault submissions hl7 rps ich guidelines