Our tailored solutions
• Flexible testing models We offer a variety of partnership and service models to match every testing program specificity – from classical fee-for-service, to scientific staffing models and end-to-end program management • Extraction procedure optimization We can develop tailored methods for detecting any relevant nitrosamines – from simple compounds such as NDMA and NDEA, to structurally complex NDSRIs – across a wide variety of drug products, drug substances and raw materials. Each method is optimized to achieve a limit of quantitation that aligns with the most recent acceptable daily intake levels set by regulatory agencies, including the US Food and Drug Administration (US FDA), Health Canada and the European Medicines Agency (EMA)
• Sample logistics We manage the seamless shipment of samples from your manufacturing site to one of our global laboratories through a trusted, audited partner. Simply send your samples and await your nitrosamine results • Scalable testing Whatever your testing needs – whether it is a few lots per year or hundreds per month – our solutions are tailored to your production scale • Fast turnaround times From sample collection to results, we can deliver within two weeks
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