Genotoxic Assessment

ICH M7 guideline provides the internationally harmonized framework for identification | classification and control of mutagenic impurities (DNA reactive compounds). It describes the risk assessment and control of DNA reactive/mutagenic impurities (genotoxic impurities) in pharmaceuticals to limit potential carcinogenic risk. Our Mutagenicity Assessment Service uses state-of-the-art computational toxicology to predict the mutagenicity of impurities in pharmaceutical compounds. This service is essential for companies aiming to ensure the safety and quality of their products while adhering to regulatory standards.