The International Council for Harmonisation (ICH) has announced two new guidelines, with one (M9) providing recommendations to support the biopharmaceutics classification of medicinal products, while ...

ICH releases draft guidelines on analytical method development The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to ...

Experts have recommended ICH Q10 PQS (International Council for Harmonisation - Pharmaceutical Quality System) guidelines on pharma quality systems for effective implementation of revised Schedule M ...

Opportunities lie in providing training for companies to modernize their stability testing programs, ensuring compliance with updated ICH and global guidelines. This is crucial for avoiding delays and ...

Key market opportunities include mastering API manufacturing complexities to ensure quality and compliance, navigating EU and USA regulatory frameworks, adhering to GMP and GDP standards, and adapting ...

Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and designing FDA-compliant stability programs ...

The session, introduced by Hans V. Hogerzeil, Professor of Global Health, University of Groningen, the Netherlands, described in more detail several current regulatory harmonization initiatives around ...