Dr A.T. Bapuji has over 26 years of strong clinical and Pharmaceutical Research and development (R&D) experience in India’s large pharmaceutical firms. Expertise in designing, planning and conducting of clinical development projects, DMPK (BA/BE) studies. Proficient in the area of human clinical Research, IVIVC, Pharmacokinetics, Bioanalysis, Biostatistics and Bio pharmaceutics. Well versed in design of clinical, pharmacokinetic studies involving BA and BE for ANDA’s and NDDS products both in healthy subjects and patients. Expertise in handling advanced analytical instrumentation like HPLC and LCMSMS in quantitation of drugs and metabolites from biological samples. Fully aware of the recent trends in US-FDA, UK-MHRA and major global regulatory Guidelines. Hands on experience in handling US-FDA, ANVISA Brazil, FRENCH (ANSM), MCC South Africa and WHO GLP/GCP Inspections.

Dr A.T. Bapuji contributed for various clinical studies in various capacities both at Ranbaxy and Aurobindo leading to filling and approval of number of ANDAs. Act as Interface between R&D team and regulatory. Successfully handled various inspections both at Ranbaxy and at Aurobindo pharma resulted significant product approvals from international regulatory agencies. Established the clinical and BA/BE departments to the highest scientific standards, helped the accelerated growth phase of the Ranbaxy and Aurobindo. Contributed in supporting more than 500 ANDA and 300 MAAs.