Nitrosamine and Nitrosamine Drug Substance Related Impurities (NDSRIs)
Our American and European Board-certified toxicologists use both traditional toxicological approaches and advanced computational tools (i.e., QSAR) to provide robust, tailored solutions that comply with global regulatory requirements on a retrospective or proactive basis. Let us help you avoid costly recalls, non-compliance penalties, or product delays.
Services include:
- Assistance with the Carcinogenic Potency Categorization Approach (CPCA) for NDSRIs
- Read-across support for alternative NDSRI surrogate selection using QSAR software
- Support for nitrosamine-specific in vitro and in vivo genotoxicity testing including study design, CRO selection, and study placement, as well as review of protocols and reports
- Acceptable intake derivation for alternative NDSRIs using robust surrogate data and QSAR support
- Evaluation of risk assessment reports prepared by other companies or study reports documenting nitrosamine impurities in pharmaceutical products to ensure compliance with regulatory requirements
- Preparation of comprehensive toxicological risk assessments and regulatory responses which communicate any identified risks to patient safety associated with the manufacturing processes for pharmaceutical products and NDSRI carcinogenic, mutagenic, and/or genotoxic potency
- Support for the development and implementation of strategies to control nitrosamine impurities in the manufacturing process