Cynthia Molina
Regulatory Consultant

Ms. Molina has 23 years experience in multiple facets of product development for pharmaceutical, biologic, medical device, and in vitro diagnostic products. Her background includes regulatory affairs, clinical and preclinical strategic planning, quality assurance, process development and manufacturing. Ms. Molina has experience preparing INDs, NDAs, 510Ks, PMAs, European investigational and marketing submissions, clinical protocols and reports, and safety reports. She has led meetings with FDA representatives, conducted compliance audits, and acted as a company representative for FDA audits. Her experience includes organizing and managing new products for both large and small corporations, including Abbott Laboratories, Murex Biologicals, and Aronex Pharmaceuticals where she was Assistant Director of Regulatory Affairs. Ms. Molina received her BA in Biology from Rice University.