Akshata Mural Email & Phone Number

Current Role: Research scientist (Feb’19- Present)Having sound knowledge on GLP, GCP, and GDPKnowledge about ICH E6 guidelines and workflowAssists in preparation and review of project related reportAssists in review of project related activities Raw data and experimental data Hands-on experience in activities like Bio-Analytical method development, Validation, Routine batch sample analysis.( Bio availability and Bio equivalence studies) Good Knowledge on phases of clinical trials following the standard operating procedures and in consistent manner with regulatory guidelines DCGI,CDSCO, TPD, USFDA,TGA, ICH, GLP, EMEA guidelines, Review of raw data and experimental dataReview of raw data and experimental data Possess knowledge in operating and handling the activities in compliance to Regulatory and sponsor requirements. Adapt in maintaining co-ordination with team to ensure completion of project activities within timeline ,An effective communicator.Performing Validation/Study sample analysis protocol, Standard Testing Procedures. Performing BA/BE Studies, Development and Validation of Bio analytical Methods as per Regulatory and sponsor requirements. Software skills Operating of LC-MS/MS (AB Sciex – API , 4000, Q)Microsoft Office and good knowledge on basic computer applications.