Assessment of Toxicological Studies

The assessment of toxicological data is of relevance for all applications of chemical products. Combined with exposure information, it is a prerequisite for the characterisation of potential risks for human health and the environment.

Certain ingredients of cosmetic products as dyes require an authorisation following submission of dermatological and toxicological data as a pre-condition for inclusion in the list of authorised substances.

For the marketing authorisation of medicinal products, preclinical data are reported in the dossier in accordance with ICH Guidelines. Potential mutagenic impurities are assessed according to ICH M7 (CTD Modules 2, 3, and 4). We offer to summarize and evaluate the required information on your behalf.