Articles tagged with “ectd-v4-0”

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 Software Guide for Small Pharma: Compliance & Timelines

Learn how to choose eCTD software for small pharma. This guide covers regulatory compliance, global submission timelines for FDA & EMA, and eCTD v4.0 updates.

35 min read

1/14/2026

ectd software regulatory submissions ectd v4.0 small pharma regulatory affairs fda ectd ema ectd ich guidelines biotech

eCTD Publishing Process: A Guide to Regulatory Submissions

Learn the complete eCTD publishing process for regulatory submissions. This guide explains the eCTD format, XML backbone, workflow, and global requirements from

55 min read

1/13/2026

ectd ectd publishing regulatory submissions regulatory affairs fda submissions ectd v4.0

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

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