Charles River performs GMP-compliant stability studies for biopharmaceutical and pharmaceutical products as well as drug substances at all stages of the registration process. We have considerable experience designing and conducting testing programs to support early development, formal submission studies per International Conference on Harmonisation (ICH) guidelines and commitment studies for the continued marketing of existing drug products.
This experience has been gained through more than 20 years of stability testing and successful support of clients' product applications. Charles River has been approved as a named laboratory on multiple product licenses by the US Food and Drug Administration (FDA), US Department of Agriculture (USDA) and European regulatory authorities.
To see case study examples of stability testing programs, please view our webinar titled Supporting Stability Data through the BLA Process.