Compare CDMOs with ICH stability testing capabilities. Filter by chamber capacity, ICH condition support, and regulatory filing experience.
Stability testing determines how a drug product changes over time under defined storage conditions (temperature, humidity, light). ICH guidelines (Q1A-Q1E) specify the conditions, timepoints, and statistical analysis methods used globally. Stability data is required for regulatory submissions to establish shelf life and storage conditions.
CDMOs offering stability services need: validated stability chambers (temperature and humidity controlled), GMP-compliant analytical testing capabilities, sample management systems for multi-year programs, and regulatory expertise to design study protocols that support global filing strategies.
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