Hire Tejaskumar J. Thakkar, a pharma consultant specializing in Analytical Testing and Clinical Studies. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Tejaskumar J. Thakkar is a pharmaceutical bioanalytical and analytical research professional with over 13 years of experience in method development, method validation, and laboratory support for bioavailability and bioequivalence studies. His expertise includes LC-MS/MS analysis of drugs and metabolites in biological samples, nitrosamine impurity analysis, sample extraction optimization, and bioanalytical study documentation.
Tejaskumar supports analytical and bioanalytical method development for drug and metabolite quantitation in biological samples and nitrosamine impurity analysis. His experience includes LC-MS/MS parameter optimization, matrix-specific method development, and sample preparation using protein precipitation, liquid-liquid extraction, and solid-phase extraction. He also supports pre-validation experiments, method transfer, and preparation of method SOPs and standard test procedures.
Tejaskumar supports clinical pharmacology studies through the bioanalytical activities required for bioavailability and bioequivalence assessments. His experience includes study sample receipt and storage, analysis scheduling, chromatogram review, incurred sample reanalysis, and preparation of drug concentration profiles. He also reviews pilot study results to support planning for pivotal studies and coordinates with clinical, medical writing, and statistical teams.
Tejaskumar supports analytical and bioanalytical method validation through experience evaluating selectivity, sensitivity, precision, accuracy, recovery, matrix effects, dilution integrity, and stability. His work includes validation protocols, data compilation, report review, and partial validation following method transfer. He brings experience with human plasma and other biological matrices, including methods for endogenous compounds and liposomal drug measurements.
Tejaskumar contributes bioanalytical specifications and laboratory inputs to BA/BE study protocols. His experience includes reviewing bioequivalence protocols and clinical updates, preparing method validation protocols, and working with bioanalytical study plans. He helps teams align sample analysis activities with validated method capabilities and provides protocol-related training to laboratory personnel.
