SciLucent’s staff includes scientific, medical, and regulatory professionals with expertise and experience in all aspects of healthcare product development and marketed product support.
Timothy J. McGovern, Ph.D.
Preclinical Program Development and Implementation; Regulatory Strategy, Documentation, and Implementation
Tim McGovern provides regulatory and pharmacology/toxicology advice regarding pharmaceutical products. Tim assists sponsors in interpreting data, developing streamlined nonclinical programs that address critical regulatory issues, designing nonclinical study protocols, including those for carcinogenicity studies, and preparing submissions to regulatory agencies. He has extensive experience as team leader and reviewer in the FDA’s Center for Drug Evaluation and Research (CDER) Divisions of Pulmonary and Allergy Products and Anesthesia, Analgesics, and Rheumatology Products and provided consultation to CDER’s Office of Generic Drugs and FDA’s Centers for Biologic Evaluation and Research and Devices and Radiological Health. Tim co authored the FDA Guidances on the safety qualification of genotoxic impurities and unique human metabolites. He represented FDA on the Product Quality Research Institute Working Group on leachables and extractables in orally inhaled and intranasal drug products. His expertise includes pulmonary, analgesic, critical care, and anesthetic drugs, as well as the safety qualification of genotoxic impurities, leachables and extractables, and unique human metabolites.
