Articles tagged with “ich-guidelines”

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 and WHODrug standardize coding for adverse events and medications in clinical trials. This guide covers their structure, use, and best practice

Learn how to manage protocol deviations in clinical trials. This guide covers classification, reporting, and prevention to ensure data integrity and GCP complia

Learn about the ICH Q8 guideline for pharmaceutical development. This in-depth guide explains Quality by Design (QbD), QTPP, CQAs, and the design space concept.

A comprehensive 2025 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)

This article provides a technical overview of pharmacovigilance software, detailing core functions, regulatory compliance, and a comparison of leading platforms.