Velvizhi

Heine

PhD, RAC

Vice President, Regulatory CMC

Velvizhi Heine joined Syner-G in 2018 and brings more than 20 years of biopharmaceutical experience in analytical development, quality control, and Regulatory CMC. She leads a team supporting biologics and small molecule products, with a strong record of guiding timely regulatory submissions for global health authorities.

Her expertise includes analytical method development, validation, regulatory strategy, and CMC submissions spanning IND, BLA, MAA, and post-approval filings. She has overseen more than 500 regulatory submissions and has prior experience at Biogen and Illumina. Velvizhi holds a Ph.D. in Biochemistry and Cancer Biology and completed postdoctoral research at Harvard Institutes of Medicine and Harvard Medical School.

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