More than 20 years of experience in Analytical Method Development, Analytical Method Validation, Method Transfer across sites, Standardisation and Qualification of Reference Standards, Stability studies as per ICH guidelines, DMF filing and answering regulatory queries.
Familiar with QbD concept, DoE studies, interpretation of toxicity data using various softwares such as TOPKAT, DEREK etc, ICH guidelines, US FDA requirements, Lab compliance, setting up of analytical laboratory etc.
Well versed with Analytical techniques such as HPLC, UPLC, GC, XRD, NMR, DSC, TGA, ION CHROMATOGRAPHY etc.