Raan Krishna
Ph.D.
Regulatory Affairs
Raan Krishna brings twenty-five plus years of biopharmaceutical industry experience with sound biological science and chemical background of small molecules and biologics (polyclonal and monoclonal antibodies/ biotechnology-derived humanized recombinant proteins) in the development of drugs and biologic in-vitro diagnostic products. Over eighteen years of regulatory affairs experience from advancing positions held in pharmaceutical/biotechnology companies (including Senior Director, Genzyme, formerly SangStat Medical Corporation; Yamanouchi Pharma Technologies, now Astellas Pharma Inc. and Coulter Corporation formerly, now Beckman-Coulter.). Responsibilities included: providing strategy and tactical guidance on domestic and international regulatory submissions, efforts that resulted in successful regulatory filings, clinical studies and regulatory authorization to market product. Ensure completion of scientific goals and corporate objectives according to regulatory guidelines as well compliance requirements. Oversee and review of scientific data from preclinical to late stage clinical development products for presentation/ regulatory submissions. Organize meetings with appropriate regulatory agency (meetings such as: pre-IND, IND, end of clinical phase 1, 2 or 3; pre-BLA/ pre-NDA; compliance and safety issues and lifecycle management of marketed pharmaceutical products).
Raan did postdoctoral work at the Washington University School of Medicine, St. Louis, MO and Cornell University Medical College, New York, NY, in molecular biology and enzymologist; later research was in microbiology, immunology and infectious diseases in Zurich and St. Gallen, Switzerland. He earned M.Sc., in Chemistry and Ph.D., in Biochemistry from the University of Mysore, India.
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