VidyaSagar Jenugu

product development regulatory submissions outsourcing compliance quality assurance New product development Invitro/Bench testing preclinical/Clinical studies documentation DeviceMasterFiles(DMF) Technical files Biocompatibility studies Animal studies Clinical trials invitro/Bench studies product complainthandling RCA CAPA Rejection analysis product&technology development FDA Quality Systems ISO9001 ISO13485 Quality Management Systems HPLC LC-MS SEM GC UV-Vis Spectrophotometer IR Spectrofluorimeter USPDissolution apparatus ELISA Gel documentation PCR Polygraphy Ultrasonic spraying coating techniques NONMEM WINNONMIX WINNONLIN RamKin GraphPadPrism Instat Rateverted intestinal model double-syringe method Pharmacokinetic and bioavailability studies Druginteraction studies Invitro protein binding Tissuedistribution studies Metabolism studies Cell culture techniques invitro cytotoxicity anticancer activity Culturing of rat primary hepatocytes Microbial metabolism studies Estimation of free radicals lipid peroxides biochemical tests Glucose uptake studies Dissection cannulation handling of laboratory animals Screening of NCEs toxicity evaluation SAS

results-oriented problem-solver Decisive leader passion for innovation teamwork collaboration Program/Project Management Risk Management Risk Analysis