Velvizhi Heine, Ph.D., RAC

Director, Regulatory Affairs

Velvizhi earned her Ph.D. in Biochemistry from the Cancer Institute in Chennai, India and her BS/MS from the University of Madras in India. She is a pharmaceutical professional with strong background and experience in CMC Regulatory/Quality and Analytical Sciences for biologics, medical device and IVD industries. She has strong experience in method development and validation of analytical assays including bioassays and process impurity assays for a wide range of biopharmaceutical products including monoclonal antibodies, recombinant proteins, biosimilar, blood coagulation factors, enzymes and cell derived vaccine. Track record experience in QC, Analytical development, CMC and CRO management. Authored sections for BLA, 510K and PMA submissions; hold US Regulatory Affairs Certification (US RAC). Experience in drug product release sample testing, support for internal and external lab audits; proven record of scientific presentations at several national and international conferences. Strong organizational and communication skills with the ability to manage multiple projects simultaneously.