By Qualification, Mr. Fedorov graduated from the Chemistry Department of Lomonosov Moscow University (Russia) in 1979. He has more than 20 years of rich experience in research and development in bio-analytical CROs of Canada.
Prior to joining Lambda, Mr. Fedorov was associated with Biotrial and has contributed immensely towards the development and validation of several hundreds bio-analytical LC-MS/MS methods.
By Qualification, Mr. Gunjan Soni is a post graduate in Organic Chemistry with more than 20 years of experience in the bioanalytical domain. He has been associated with Lambda for more than 18 years. Mr. Soni is functioning as Senior General Manager – Bioanalytical and is responsible for the RD activities at Lambda. He has been involved in the method development and validation of several methods. Mr. Soni has faced several Regulatory inspections from almost all leading regulatory bodies like USFDA, EMA, ANVISA, WHO, NPRA Malaysia and others.
By Qualification, Mr. Pravin Patel is post graduated in Analytical chemistry from the School of Science, Department of Chemistry, Gujarat University, Ahmedabad, Gujarat (India) in 2002. He has been with Lambda for over 17 years. He has contributed significantly towards the development and validation of several hundreds of bio-analytical LC-MS/MS methods in areas like BA/BE, NCE and in vitro studies. He has also faced audits and inspections from leading regulatory bodies including but not limited to DCGI, USFDA, ANVISA, WHO, Malaysia, EMA etc.
By Qualification, Mr. Arpit Joshi is post graduate in indusial chemistry from the Institute of science and Technology for advanced studies and research (ISTAR) college, V.Vnagar, Anand, Gujarat (India) in 2002. He has been with Lambda for over 16 years. He has contributed significantly towards the development and validation of several hundreds of bio-analytical LC-MS/MS methods in areas like BA/BE, NCE and in vitro studies. He has also faced audits and inspections from leading regulatory bodies including but not limited to DCGI, USFDA, ANVISA, WHO, NPRA Malaysia, EU-MHRA_UK.
Dr. Vipul Rajput is Heading Clinical Laboratory Department at Lambda , by qualification He is MBBS and MD Pathology & Microbiology from M.S University. Dr.Vipul has more than 22 years of rich experience in Clinical Research and Hospital industry. He is also a qualified assessor as per ISO:15189 from NABL-National Accreditation Board for Testing & Calibration Laboratories, QCI, India. Dr.Vipul has successfully managed several regulatory audits, inspections from leading regulatory bodies, College of American Pathologists and NABL.
Ms. Pallavi Hajela comes with more than a decade of experience in developing, validating and transferring immunoassays for Pharmacokinetic, Pharmacodynamic measurement and Immunogenicity assessment. Her qualification includes M.Sc. in Pharmaceutical Chemistry and Executive General Management Program from IIM, Bangalore. Prior to joining Lambda, she had worked with Biocon Research Limited, Dr. Reddy’s Laboratories and Intas Pharmaceuticals. Pallavi leads the niche Bioanalytical (Proteins and Biosimilars) group which works on the bioanalytical studies of biological therapeutics for pivotal submissions to regulatory agencies.
By Qualification, Dr.Bhavin is an MBBS and M.D in Microbiology, from Gujarat University, India. Dr.Bhavin has over 19 years rich experience in field of Clinical Pathology and Microbiology. He has been with Lambda for over 14 Years. He is Technical and Lead Assessor for NABL (National Accreditation Board for Testing & Calibration Laboratories, QCI (Quality Council of India) and Inspector for College of American Pathologist Accreditation. Apart from the Clinical Lab Safety testing, he is primary responsible for Invitro, Ex-vivo and Clinical Microbiology related studies. He has numerous National and International publication. He is active member of IAMM (Indian Association of Medical Microbiologist), IADR (International Association of Dental Research), Hospital Infection Society, India.