Safety evaluations impurities
Controlling and toxicological assessment of impurities is mandatory in Drug substance development. We can support you on :
- Risk assessment and qualification strategies for impurities in drug candidates and drug products according to the ICH Q3 guidelines.
- Database & literature searches for genotoxicity and carcinogenicity data.
- In silico toxicology assessment using (Q)SAR methodologies to predict mutagenic potential according to ICH M7 guideline.
