Stability Testing

Charles River's Biopharmaceutical Services group (BPS) performs stability studies required at all stages of the registration process for biopharmaceutical and pharmaceutical materials. We have considerable experience designing and conducting programs to support early development, formal submission studies to ICH guidelines, and commitment studies to support the continued marketing of existing products. This experience has been gained through over 10 years of stability testing and successful support of product applications.

Studies are conducted to current Good Manufacturing Practice.  Charles River has been approved by the US FDA and European regulatory authorities as a named laboratory on product licenses.

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