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.

Our Focus:

At Syner-G Pharma Consulting, Chemistry, Manufacturing and Controls (CMC) is our sole focus. We offer a complete suite of CMC solutions (CMC-360) in the following three core areas: Regulatory Affairs, Pharmaceutical Development, and QA/cGMP Compliance.

Contact Us:

Syner-G Pharma Consulting, LLC
371 Turnpike Road
2 Park Central Drive, Suite #110
Southborough, MA 01772
(508) 460-9700

Privacy Settings
We use cookies to enhance your experience while using our website. If you are using our Services via a browser you can restrict, block or remove cookies through your web browser settings. We also use content and scripts from third parties that may use tracking technologies. You can selectively provide your consent below to allow such third party embeds. For complete information about the cookies we use, data we collect and how we process them, please check our Privacy Policy
Consent to display content from Youtube
Consent to display content from Vimeo
Google Maps
Consent to display content from Google