Articles tagged with “ema”

Learn eCTD publishing best practices for compliant regulatory submissions. This guide covers technical standards, validation, and requirements from FDA, EMA, an

Learn the fundamentals of eCTD sequence management for compliant regulatory submissions. This guide explains sequence numbering, lifecycle operations, and best

Learn about eCTD regional variations for global regulatory submissions. This guide compares Module 1 requirements from the FDA, EMA, Health Canada, and more.

Learn the essential eCTD validation requirements for regulatory submissions to the FDA and EMA. This guide covers technical specifications, business rules, and

Explore key challenges in pharmaceutical regulatory submissions, from legacy eCTD issues and CMC gaps to the rise of AI and structured data for faster drug appr

An educational guide comparing the EU Risk Management Plan (RMP) vs. the US REMS for drug safety. Learn about key differences in scope, content, and triggers.

Learn how simple pharmaceutical translation errors in an SmPC or patient leaflet can lead to major drug recalls, regulatory sanctions, and patient safety risks.

Learn about the EU Clinical Trial Regulation (CTR) 536/2014 and the CTIS portal. This guide covers harmonized submission processes, key timelines, and transpare

Learn the 9 ALCOA+ principles for GxP data integrity. This complete guide explains each attribute, FDA & EMA regulations, and compliance for pharma and life sci

A comprehensive guide to regulatory requirements and best practices for implementing compliant Randomization and Trial Supply Management (RTSM) systems in clinical trials, covering FDA, EMA, and global standards.