Dr. Satish Bhatia
(Medical Advisor)
Dr. Satish Bhatia has over 30 years of international experience in pharmaceutical R and D. He served Ciba-Geigy (Novartis) for 17 years in various positions in their R and D labs in Switzerland, India and USA. On his return from the US in 1995, Dr Bhatia has served the Indian pharmaceutical industry by establishing, first, a GCP centre of excellence in clinical pharmacology and pharmacokinetics at the Ranbaxy R and D laboratories in Gurgaon, and then, two start-up CRO's - Wellquest in Mumbai and Fortis Clinical Research in Faridabad.
Dr. Bhatia has a PhD in Biochemistry from the University of Delhi and he carried out post-doctoral research at the University of Geneva in Switzerland. His background includes bio-analytics, drug metabolism, clinical research, quality assurance and business development.
Dr. Bhatia will be responsible for providing medical inputs into operations and business development, providing authoritative opinion and answers to queries concerning medical, legal and regulatory matters and advice on medico-marketing activities which will help DMRI explore new dimensions.
Mr. Hitesh Shah
(Vice President - Operations)
Mr. Hitesh has a Masters degree in Pharmacology and Diploma in Pharmacoeconomics with more than 11 years of rich experience in various facets of Pharmaceutical fields including API, Formulation, Regulatory Affairs, BA/BE studies and Clinical Trials. As Vice President of Operations at DMRI, Mr. Hitesh is responsible for the overall execution and operations at DMRI. He has successfully faced regulatory inspections from DCGI – India, UK MHRA, US FDA, ANVISA- Brazil, WHO, Israel- MOH. Before joining DMRI, he has worked with Wellquest Clinical Research Organisation, Macleods BA/BE centre and DIL Group (formerly duphar –Interfran Ltd.). He has international publication to his credit.
Mr. Nelson Varghese
(General Manager - Quality Assurance)
Mr. Nelson has a Masters degree in Chemistry and MBA in Clinical Research with more than 17 years of experience in API, formulations, BA/BE stuies and Clinical Trials. As General Manager of Quality Assurance at DMRI, Mr. Nelson is responsible for Total Quality Management of the systems and procedures at DMRI, Preparation / Review / Implementation of SOPs as per the DCGI / ICH – GCP / GLP / regulatory guidelines, ensuring the implementations of the quality policies and continuous training / upgradation of the personnel’s / systems including safety and environmental protection. He has vast exposure to external regulatory / sponsor audits. Before joining DMRI, he has worked with Johnson and Johnson and Merck Development Centre, India (now Mylan) in his earlier profile.
Dr. Ketan Nerurkar
(Deputy General Manager – Bioanalytical)
Dr. Ketan has a Doctorate degree in analytical chemistry with more than 9 years of experience in API, Analytical development and BA/BE studies. As Deputy General Manager at DMRI, Mr. Ketan is responsible for the overall activities involved in the bio-analytical department of DMRI and ensuring that the scientific and technical standard of the work is at the forefront of the industry. He has successfully faced audits of external regulatory /sponsor. Before joining DMRI, he has worked with Sun Pharmaceuticals, Teva Pharmaceuticals, Accutest Research Laboratories. He has also presented research paper in Indian Pharmaceutical Congress held at Delhi and Pune. He has national and international publications to his credit.
|
|