SciLucent’s staff includes scientific, medical, and regulatory professionals with expertise and experience in all aspects of healthcare product development and marketed product support.
Tracey Zoetis, M.S.
Preclinical Program Development and Implementation; Regulatory Strategy, Documentation, and Implementation
Tracey Zoetis advises clients on regulatory and pharmacology/toxicology issues for FDA-regulated products. She is known for her practical approaches to drug development and for opening effective lines of communication between sponsors and regulatory authorities. She helps sponsors work to keep nonclinical issues from becoming rate-limiting steps in an overall drug development program. She assists sponsors in interpreting nonclinical data and in preparing submissions to regulatory agencies. Tracey monitors studies to ensure that they are conducted using current technologies and are in compliance with Good Laboratory Practices. She has authored hundreds of GLP-compliant study reports, numerous FDA reviews, published over 10 scientific articles, and is the co-editor of a book on direct dosing of pre-weaning mammals in toxicity testing. Tracey is a former reviewer in the FDA Center of Drug Evaluation and Research Divisions of Pulmonary and Allergy Drug Products and Anti-inflammatory, Analgesic, and Ophthalmologic Drug Products and internal consultant to the FDA Centers for Devices and Radiological Health and Food Safety and Nutrition. Her expertise includes oncologic, cardiovascular, endocrine, renal, pulmonary, anti-infective, ophthalmic, and analgesic drugs.
