Nanda Subbarao
Senior Consultant @Biologics Consulting
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WORK HISTORY
Senior Consultant @Biologics Consulting
GMP systems design and implementation Data Integrity Laboratory Stability Equipment FDA regulatory submission preparation and review Well Characterized Proteins including Biosimilars, Stem Cell Products, Nanotechnology products, PET products, Conventional drugs Technical expertise Design and evaluation of Stability Programs Design and evaluation of Analytical method and method validation for a wide variety of products such as well characterized proteins including biosimilars, vaccines, gene therapy products, stem cell products Expert advice on regulatory and technical aspects of Particulate testing Expert advice on regulatory and technical aspects of extractables/leachables testing Expert advice on regulatory and technical aspects of immunogenicity assays Audit of Laboratory GMP/GLP systems and Advice on upgrade of GMP/GLP systems Data Integrity PAI readiness Products ranging from pre-Clinical tox phase to Clinical Phase and commercial Client training course development Explanation of FDA regulations
EDUCATION
Indian Institute of Technology, Bombay
Ph.D, Chemistry
ABOUT NANDA SUBBARAO
Senior Consultant at Biologics Consulting Group
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