About Us
Consultants
Kristy V. White, MS, PMP, CMCCP
Founder and CEO
Consultant and Global Regulatory Affairs CMC Strategist
As lead strategist, Kristy oversees the regulatory aspects of drug substance synthesis, delivery of clinical trial material (formulation development, manufacturing, analytical testing, packaging, and stability), and the chemistry, manufacturing and controls (CMC) content of regulatory submissions.
Kristy has more than 15 years of experience in the pharmaceutical/biotechnology industry. Kristy has an extensive background in small molecule product development in a variety of dosage forms, including combination products using novel and commercial devices. Kristy is a subject matter expert for oral inhalation product development (dry powder inhalers, metered dose inhalers, and nebulizers). Kristy has a proven track record for cross-functional team leadership in development of global regulatory CMC strategies to support products in development and new registrations that meet Health Authority requirements and business objectives.
Kristy is an analytical chemist by training and holds a M.S. in Chemistry from the University of North Carolina Wilmington. Additionally, Kristy holds the Project Management Professional (PMP) credential, as well as the Chemistry, Manufacturing & Controls Certified Professional (CMCCP) credential. Prior to founding Summit Regulatory CMC, LLC, Kristy held several Global Regulatory Affairs CMC positions within the Raleigh-Durham area of North Carolina.
Kristy is experienced in quality module authoring in electronic CTD format. Kristy has successfully lead numerous regulatory submissions, Health Authority meetings, and information requests.
