Articles tagged with “ich-guidelines”

Guide to eCTD v4.0 regulatory submissions. Learn about HL7 FHIR standards, document reusability, and global implementation deadlines for FDA and EMA.

Analyze global regulatory submissions, contrasting ICH guidelines with regional requirements. Learn to manage FDA, EMA, and local filing differences.

Explore eCTD lifecycle management, the core process for updating regulatory dossiers. Learn about ICH standards, submission sequences, and the shift to eCTD v4.

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.

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

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

A clear comparison of the DSUR vs. the PSUR/PBRER. Understand the distinct purpose, scope, timing, and governance of these key pharmacovigilance safety reports.

Learn how MedDRA (v29.0) and WHODrug (688K+ products) standardize coding for adverse events and medications in clinical trials. Covers structure, AI-assisted coding, regulatory requirements, and 2026 updates

Learn how to manage protocol deviations in clinical trials. Updated for ICH E6(R3) and FDA 2024 draft guidance, covering classification, reporting, and prevention for data integrity and GCP compliance.

Learn about the ICH Q8 guideline for pharmaceutical development. This in-depth guide explains Quality by Design (QbD), QTPP, CQAs, design space, and includes 2025-2026 updates on ICH Q13, Q14, and AI in manufacturing.

A comprehensive 2026 guide to ICH Q7, Q8, & Q9. Learn the core principles of GMP for APIs (Q7), Quality by Design/QbD (Q8), and Quality Risk Management/QRM (Q9)

Updated for 2026, this article provides a technical overview of pharmacovigilance software, detailing core functions, regulatory compliance, agentic AI developments, and a comparison of leading platforms including Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, and more.