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.
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Articles tagged with “pharmaceutical-regulation”
eCTD Software Comparison: A Technical Guide & Analysis
Get an in-depth comparison of eCTD software for regulatory submissions. This guide analyzes top platforms like Veeva & EXTEDO on features, pricing, & eCTD v4.0
How Generics Challenge Patents: A Hatch-Waxman Act Guide
An educational guide to generic drug patent challenges. Learn about the Hatch-Waxman Act, the ANDA pathway, Paragraph IV certifications, and the FDA Orange Book
FDA vs. EMA: Key Differences in US & EU Drug Regulation
An in-depth comparison of the FDA and EMA. Learn the key differences in US and EU drug approval processes, review timelines, GMP, and regulatory frameworks.
Japan's Drug Approval Process: A Guide to PMDA & MHLW
Learn about Japan's drug approval process. This guide covers the PMDA & MHLW roles, review timelines, drug lag, and expedited pathways like SAKIGAKE.
The EU AI Act & Pharma: Compliance Guide + Flowchart
Learn about the EU AI Act's impact on pharma. This guide explains the risk-based approach, high-risk AI rules, and compliance steps with a free flowchart & SOP
ICH M7: A Guide to Mutagenic Impurity Assessment Software
Understand the ICH M7 guideline for assessing and controlling mutagenic impurities in pharmaceuticals using in silico (Q)SAR software, TTC, and risk-based metho
Automating Audit Trail Compliance for 21 CFR Part 11 & Annex 11
An explanation of regulatory requirements for audit trails under 21 CFR Part 11 and EU Annex 11, covering automation strategies and data integrity measures.