Articles tagged with “fda-submissions”

Define-XML 2.1: Metadata QA and Reviewer Navigation

A 2026 Define-XML 2.1 implementation guide covering field-level metadata controls, FDA version selection, value-level tests, link integrity, and reviewer navigation.

19 min read

9/20/2026

define-xml 2.1 define-xml implementation metadata validation cdisc fda submissions reviewer navigation value-level metadata clinical data standards submission qa

Regulatory-Grade RWE Platforms for FDA & EMA Submissions

Learn how pharma companies build regulatory-grade real-world evidence (RWE) platforms using real-world data for FDA and EMA drug development submissions.

45 min read

4/8/2026

real-world evidence real-world data rwe platforms fda submissions ema regulations pharmacoepidemiology regulatory affairs

Cloud eCTD Submission Tools: A Pharma Compliance Guide

Explore cloud-based regulatory submission tools for pharma. This guide covers eCTD software, RIM systems, compliance (21 CFR Part 11), benefits, and challenges.

50 min read

1/15/2026

regulatory submissions ectd pharma cloud 21 cfr part 11 gxp compliance saas fda submissions

eCTD Publishing Process: A Guide to Regulatory Submissions

Learn the complete eCTD publishing process for regulatory submissions. Updated May 2026 with the latest eCTD v4.0 milestones (PMDA mandate Apr 2026, EMA optional Dec 2025, FDA voluntary, ANVISA 2026).

55 min read

1/13/2026

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