Manish Kumar Sharma, MS. Pharm (PhhD) has 4 years of pharmaceutical industry and academia experience. As a regulatory officer at Mac-Chem products he gained scientific expertise in regulatory affairs responding to query submitted dossier as per global regulatory requirement (5 US and 5 CEP filing). He has conducted hands-on data analysis, developed and applied PK, PBPK and PKPD models using WinNolin (Phoenix), NLME, Gastro-plus and Monolix software. He has also conducted in-vitro & in-vivo metabolism, pharmacokinetics and tissue distribution studies in support of small molecule drug discovery development, Bioanalytical method development and preclinical DMPK studies.
Mr. Sharma has authored/co-authored 17 publications, posters, and abstracts. He is working on defending his PhD thesis from National Institute of Pharmaceutical Education Research (NIPER), Gandhinagar. He got his M.S Pharmaceutical Analysis from Institute of pharmacy, Nirma University-Ahmedabad, and Bachelor of Pharmacy from Rajasthan University of Health Science Jaipur, Rajasthan, India.
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