Since the foundation of TKT, our experts have provided support to a large number of customers in issues related to impurities in drug products/APIs. In several cases the assignments have been of "business critical" nature and on many occasions involved problem solving. TKT offers e.g. the following services:
Risk assessment and qualification strategies for leachables/extractables in medical devices according to ISO 10993 (see also "Medical Devices")
- Risk assessment and qualification strategies for impurities in drug candidates and drug products in compliance with the ICH Q3 guidances
- ICH M7 compliant reports on assessment and control of mutagenic impurities in pharmaceuticals (Se also "Tools" and Genetic toxicology")
- Determination of Permitted Daily Exposure (PDE) in compliance with the EMA guidance (See also "Chemical Risk Assessment"