Nitrosamines are a well-known group of highly potent, mutagenic impurities formed by the reaction of secondary amines with nitrite under acidic conditions. Nitrosamines have been studied for many years due to their presence in foods, cosmetics, tobacco products, industrial solvents, and alcoholic beverages.
Expertise
In the European Union (EU), following an Article 31 review of sartans at risk of containing nitrosamine impurities (those containing a tetrazole ring),9 manufacturers will review:
Risk Analysis and Product prioritization
Risk Assessment of chemically synthesized APIs according to ICH guideline Q9.
Risk of nitrosamines is detected through help of confirmatory high sensitivity testing and mass detectors associated with liquid (LC/MS) or gas chromatographs (GC/MS)
Regulatory variations: Modifications of the Manufacturing Process or Changes in Product Specification should be notified to the Regulatory Agencies.
Advantages
Multidisciplinary team of expert toxicologists accredited by DABT , ERT
End-to-End of Toxicology Risk Assessments
Support for region-specific Regulatory complexities
Our toxicologist are certified by various International boards like DABT, ERT and FELASA with a strong experience of handling over 250+ molecules. Provided a chance we would like to understand your requirements if any and explain how we can support you with them.
DABT – Diplomate of The American Board of Toxicology
ERT – European Registered Toxicologist – United Kingdom Registry of Toxicologist
FELASA – Federation of European Laboratory Animal Science Association ‘C’ level
Swift turnaround time for PDE and OEL reports.
Experience in drug discovery and development
Hands-on experience of in vitro and in vivo toxicology studies
About Us
Welcome to Maven, one of the best Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Maven understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Maven works with any range of company that is looking for quality and in time delivery of services.