Cynthia Fink, MPH

Cynthia (Cindy) Fink provides scientific, regulatory, medical writing, and management consulting services to the healthcare industry.  She is a knowledgeable regulatory affairs professional with over 25 years of experience in the field, designing and implementing regulatory strategies for U.S and international clients.  She is well-versed in U.S. Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) regulations and has led or participated with interdisciplinary teams guiding biologics, drugs, and medical devices through the regulatory and clinical processes towards marketing approval.  In addition, Cindy has extensive experience in strategic development and preparation of Orphan Drug Designation requests.  Cindy has strong analytical skills with expertise in the development of clinical programs, design of clinical studies, and interpretation of clinical data, and she is the company’s liaison with biostatisticians and clinical data management vendors.  She provides strategic medical writing contributions for the preparation pre-meeting packages, Investigational New Drug (IND), and Marketing Applications.  Cindy has a M.P.H. in Epidemiology and Biostatistics from The George Washington University, School of Public Health in Washington, DC.