Coua Xiong-Vang, PharmD, MHA

Coua Xiong-Vang is a clinical development and regulatory affairs professional, providing regulatory and technical support in healthcare product development.  She specializes in regulatory project management, specifically for Investigational New Drug Applications (INDs) for filing to the U.S. Food and Drug Administration (FDA).  Coua has experience in various therapeutic areas including infectious disease, cardiovascular, oncology diseases and pharmacogenomics.  She has managed and authored clinical and regulatory sections of INDs and New Drug Applications (NDAs) for submission, as well as Standard Operating Procedures (SOPs), clinical trial documentation (e.g., protocols, ICFs), and accelerated pathway designation requests (e.g., Orphan Drug Designation Requests).  She also has experience in publishing electronic files for submission to the FDA.  In addition, she has experience performing clinical quality assurance functions and has completed client audits. Coua brings pharmacy and field perspective to her consulting work, having experience in several settings including hospital, community, biotechnology, and pharmaceutical manufacturing.  Coua has a MHA from Pfeiffer University and a PharmD from Presbyterian College School of Pharmacy.