I can support you with the entire lifecycle of risk management and mitigation of nitrosamine impurities in medicines, including NDSRIs (Nitrosamine Drug Substance-Related Impurities), or specific aspects depending on your needs:

• Conducting detailed nitrosamine risk assessment on APIs, excipients and drug products (manufacturing, packaging, and stability), including the design of risk-assessment supporting lab experiments. I provide both reports for internal use and packages that can be seamlessly integrated into regulatory submissions to meet regulatory expectations. On request I organize and coordinate external lab experiments.

• Proposing strategies for analytical testing for identified nitrosamines, including reference standard synthesis. On request, I provide coordination of confirmatory testing activities with external laboratories, including reference standard synthesis and qualification.

• Evaluation of confirmatory testing results and root cause analysis.

• Literature studies on nitrosamine-related research questions.

• Design of acceptable intake limit recommendations including the development of weight-of-evidence approaches, development of read-across approaches and confirmation or comparison of acceptable intake limits based on CPCA (Carcinogenicity Potency Categorization Approach), interpretation of available data and suggestions for data generation. On request, I offer advisory and technical coordination support for such suggested toxicological studies (in silico/in vivo/in vitro) like the Enhanced Ames Test (EAT), metabolism studies, computational mechanistic studies (like quantum mechanical (QM) calculations and cytochrome P450-NDSRI binding studies via molecular docking), and in vivo and in vitro mutagenicity assays.

• Design of transitional measures like temporary less-than-lifetime (LTL) limits and measures, routed in the available testing data and the safety justifications on the product.

• Providing expert guidance on current regulatory options, while actively preparing and anticipating for anticipated future regulatory guidance evolutions.

• Design of remediation strategies to reduce nitrosamine content.

• Writing research reports, literature papers and submission documents based on your available data to reduce your administrative burden.

• Writing and reviewing your internal approaches to nitrosamine impurities.

• Support with the interpretation of Request for Information (RFIs) on nitrosamine topics from different international regulators, proposing response strategies and preparing proposals for response letters.

• Providing training on nitrosamine-related topics (F2F, online or in writing).

I offer support on an hourly or a project basis. I work remotely but am available for international travel depending on your needs.

Where needed to meet regulatory requirements, I offer rush services.

On request, I offer exclusivity on an API basis.

I also offer package deals and set-ups guaranteeing continued support per NDSRI. You can also explore some of our standardized offerings in the Store.

Please contact me to discuss how I can support safeguarding your portfolio. I actively follow nitrosamine guidance and its implementation for the European Union, United Kingdom, Switzerland, USA, Canada and Australia and I maintain regulatory experience in other international territories as well.