Shanthi is an Associate Director within Apotex Global R&D and a CMC (Chemistry Manufacturing Controls) Subject Matter Expert with 25+ years of experience across the pharmaceutical and biopharmaceutical areas. She provides scientific leadership and strategic oversight for the development and commercialization of biosimilars and complex generics.
Shanthi has led and contributed to key Biosimilars CMC activities, including technical due diligence, product development, analytical characterization and similarity assessments, technology transfer, and post-approval lifecycle management.
Her expertise and leadership have directly supported successful regulatory submissions, regulatory agency interactions, product approvals, commercial launches, and ongoing product stewardship.
Shanthi has a Bachelor’s degree in Chemistry; Master’s and PhD degrees in Biochemistry – all from the University of Madras, Chennai, India.
