Dr. Sundar Ramanan brings over 25 years of experience across biopharmaceutical drug development to commercialization lifecycle, with strong emphasis on Quality and Regulatory compliance. His career spans both product development global companies such as Amgen, Baxter and Biocon, and CDMO Just-Evotec biologics. His notable accomplishments include FDA and EMA cGMP approval for manufacturing facilities, advancing regulatory policy with FDA leading to Phase-3 waiver for insulin and thereby enabling the 1st FDA approval for a biosimilar with interchangeability rating without Phase-3 in the US. Dr. Ramanan is chemical Engineer by training and holds a PhD in Bioengineering from Oregon State University and an MBA from University of Michigan. He is also an accomplished speaker and author. His most recent publication is a book titled “Orphan Drug Development for Rare Disease” RAPS 2021. As CQO, Sundar will oversee the quality unit in India and lead its expansion into the U.S. market. In India, he will manage the quality operational functions, including QA and QC, while also overseeing the centralized quality system and the quality engineering & validation units