At Aragen, we routinely evaluate drug substance and drug product stability under different ICH conditions. Our stability storage facility consists of walk-in and reach-out chambers, refrigerator and freezer storage and is fully secured with 24/7 electronic monitoring, alarm and power backup. Samples are analyzed using stability indicating analytical methods (SIAM) to enable data integrity, reliability and trend analysis. Our robust quality assurance systems ensure close monitoring, review and approval of stability studies before release of reports.
Aligning EHS and sustainability initiatives with strategic business value.
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