Dr RaghunadhaReddy Seelam

      

Dr RaghunadhaReddy Seelam

Consulting Editor: Seelam Raghunadha Reddy (PhD)

Post Doc Scholar, Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA

Dr.S.Raghunadha Reddy has completed his PhD at the age of 30 years from Jawaharlal Nehru Technological University Anantapur and currently as postdoctoral reseach scholar from Department of Pharmaceutical Science, School of Pharmacy, University of Maryland, working on projects funded by extramural grants (RO1 and UO1) from the National Institute of Health (NIH) and the Food and Drug Administration (FDA). Previously he was headed the Quality Assurance and Regulatory Affairs teams  at Clinsync Clinical Research Pvt Ltd. He has published 17 papers and 7 posters in reputed journals/ International Conferences. He has 8+ years of experience in Good Clinical Practice-ICH, Clinical Research (Phase trials and BA/ BE studies), Invivo-Invitro correlations(IVIVC), Pharmacokinetics, Good Laboratory Practice, Quality Assurance, Quality Management Systems (ISO9001-2008), Bioanalytical method Development and validation, Computer System Validations (21 CFR Part-11) and Regulatory Affairs(USFDA and Indian FDA). He has developed and validated 35 bioanalytical methods, and analyzed the thousands of healthy and patient subject samples for different categories of molecules on LC-MS/MS. He has conducted more than 150 CRO "system and study specifc" audits and more than 50 audits for selection Vendors for CRO's. He has good exposure in National and International regulatory and Sponsor audits- DCGI(India), USFDA, EMEA, HPFB(Canada), MHRA(UK), BPFK(Malaysia), Turkey and PAHO countries