Quynhnhu Nguyen

With over 17 years of experience in both consulting and FDA regulatory review evaluations, QuynhNhu Nguyen is the Director, Human Factors at Kymanox.

QuynhNhu has over 15 years of FDA regulatory science and evaluation experience with human factors, medication errors, and product design and development, reviewing 900+ medical products (devices, drugs, biologics, and combination products) that covered all therapeutic areas from various phases starting with investigational product applications to marketing applications to post approval supplements.

QuynhNhu has about 2 years of HF regulatory consulting with Kymanox and has supported 45+ projects serving small, medium, and large pharmaceutical companies in ensuring comprehensive HF program executions with data-driven regulatory strategies and “Right First Time” submissions.

QuynhNhu earned a Master of Science Degree in Systems Engineering from Johns Hopkins University and a Bachelor’s degree in Biomedical Engineering from George Washington University.