Our Team

Vidhya joined Biologics Consulting in July 2022 and has over ten years of experience in analytical development and quality control, including five years of experience authoring regulatory submissions for FDA, EMA, and MHRA.

Vidhya previously worked for bluebird bio as a Senior Analytical Product Lead where she served as the single point of contact for authoring and coordinating analytical updates for clinical and commercial regulatory filings. She authored Module 3 submissions for two BLAs and developed responses to FDA Information Requests.

Prior to bluebird bio, she worked at Corbus Pharmaceuticals as a Manager in Analytical Development. Here Vidhya managed method development, validation, and transfer for small molecule drug substance and drug product at CMOs in a fully virtual company. She also authored analytical sections of IND and IMPD submissions and prepared CMC sections of FDA briefing documents. .

Vidhya received her B.A. in Chemistry from Boston University and her M.S. in Pharmaceutical Sciences from University of Florida.