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Pharma Stability: Insights, Guidelines, and Expertise

Tag: EMA zone IVb requirements

Global Regulatory Trends in Real-Time Stability Study Requirements

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Global Regulatory Trends in Real-Time Stability Study Requirements Global Trends in Regulatory Requirements for Real-Time Stability Studies Real-time stability testing is an essential part of pharmaceutical product development and global regulatory submission. While the core scientific principles are harmonized under ICH guidelines, each regulatory body imposes region-specific nuances that must be considered for compliant product…

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  • Match Stability Study Container-Closure Systems to Final Market Packaging

    Understanding the Tip: Why container-closure systems matter: Stability testing simulates how a drug product will behave over its shelf life.
    If the container-closure system used… Read more

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