It is with great pleasure, we introduce our company Itrace Pharmaceutical Solutions Pvt. Ltd. Our team of highly enthusiastic, skilful and experienced individuals is fully equipped with the latest technology and is ready to satisfy your needs and demands. To fully apprise you with our capabilities and the range of services that we offer, I have attached our details. Our major service offerings include: • Extractables and leachable studies for drug products and medical devices • N-Nitrosamine testing as per the current regulatory requirements • Genotoxic impurity testing • Method development, validation and analysis for Assay, Related substances and other impurity analysis in different drug substances and drug products • Genotoxic impurity testing • Elemental analysis as per ICH Q3D, USP 232 and 233 (wherever applicable) • Glass delamination studies Multiple activities performed at Itrace such as E&L studies, Nitrosamine method developement and validation, HPLC & GC Method developement and validation, Elemental analysis as well as Glass delamination studies are submitted to regulatory markets (US, Europe, WHO etc.)
