Danielle Ruiz, MS, RAC

Senior Consultant

Danielle is a clinical and regulatory affairs research professional with experience and understanding of the regulatory aspects of drug and biologic development, as well as of animal models and cellular systems for research purposes. She has managed the preparation of and drafted regulatory documentation including regulatory agency meeting requests and meeting packages, clinical study reports and protocols, standard operating procedures, and clinical electronic common technical document sections required for INDs and NDAs. Danielle also has experience performing clinical quality assurance functions and conducting clinical site audits to verify compliance with Good Clinical Practices. She has experience working in several therapeutic areas such as neurology, rheumatology and autoimmune disease, genetic disorders, and infectious disease. Danielle has a B.S. in Biological Science from the Virginia Polytechnic Institute and State University and an M.S. in Biotechnology, with a Concentration in Regulatory Affairs from Johns Hopkins University.