Ms. Duong joined DataRevive as Director, Regulatory Affairs with over 16 years of pharmaceutical/biotech experience in global strategic development, licensing and post-marketing regulatory activities for drug, biological and biotechnology products.

She has extensive experience in regulatory affairs including managing (from authoring to submission) original INDs/CTAs and global marketing authorizations (NDAs/BLAs/MAAs/ANDAs) as well as routine submissions (IND amendments, DSUR/Annual Report/post-approval supplements) along with Breakthrough Therapy and ODD applications with success. This includes strategic negotiations with US FDA (EOP2, Type C, PSP/PIP) and global regulatory authorities to gain valuable feedback.

She has in-depth expertise in the development and management of early to late-stage drug development program with global collaborators and partners (China, Japan, and EU). Her skills go beyond the regulatory from program management to managing timelines, clinical budget and leading the marketing authorization GCP inspection readiness along with managing the eTMF system.  Ms. Duong earned her B.S degree in Chemistry and M.S degree in Clinical Science from the University of Montréal.