Genotoxic and Carcinogenic Assessments

Superior Toxicology & Wellness can expertly assist your company in complying with the FDA and EMA requirements on Genotoxic and Carcinogenic impurities. 

This service helps pharma companies comply with FDA and EMA requirements from ICH M7 on Genotoxic and Carcinogenic Impurities. This regulation contains a Guideline on the Limits of Genotoxic Impurities – (EMEA/CHMP/QWP/251344/2006); and Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (M7). 


Superior Toxicology & Wellness can provide the expertise to create these reports based on sound science and backed by 30 years of toxicology experience working with small and large companies regardless of where your company is located.