Area of Expertise:
Kristy White, MS, PMP, CMCCP
Kristy White provides regulatory affairs; chemistry, manufacturing, and controls (CMC); quality assurance; and technical support to the healthcare products industry. Her experience includes pharmaceuticals, biologics, and combination products. Kristy specializes in developing and implementing regulatory CMC strategies for investigational and commercial products in global markets, including products with novel devices or manufacturing technologies. Additionally, her experience includes regulatory writing and submission support, integrated project management, quality assurance support, and scientific/regulatory issue research and analysis. Prior to working in Regulatory Affairs CMC, Kristy spent more than 9 years in research and development specializing in inhaled therapies. Kristy has M.S. in Chemistry from the University of North Carolina. Additionally, she maintains PMP and CMCCP certifications.