Genetic toxicology

Genetic Toxicity is a highly specialized field within toxicology where TKT can offer experienced and dedicated expertise. Since the foundation of TKT, our experts have provided support to many customers in issues related to potential genotoxic impurities (PGIs) in drug products/APIs. In several cases the assignments have been of "business critical" nature and on many occasions involved problem solving. Please, do not hesitate contacting TKT for further discussions on how TKT can provide the right support. TKT offers e.g. the following services:

  • Evaluation and design of genetic toxicology strategy for you project needs in compliance with the regulatory guidelines
  • Design, monitoring and evaluation of both non-regulatory and regulatory genotoxicity studies
  • Genotoxicity risk assessments of medical devices according to ISO 10993
  • In silico predictions of potential mutagenicity / carcinogenicity employing mainstay (Q)SAR models accepted by regulatory authorities (see also "Tools")