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 ...

The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for late-stage pre-approval or ...

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 ...

Advanced kinetic modeling (AKM) can accurately describe the complex behaviors of biologics, reducing risks from the developmental stage all the way through last-mile delivery. Importantly, regulators ...

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

Preserve study integrity. Resist the temptation to bolt new exploratory endpoints midstream. If an additional endpoint is ...