​Dr. Tim McGovern and Dr. Todd Bourcier, co-founders of White Oak Regulatory Tox, LLC, offer specialized consulting services in nonclinical drug development, regulatory toxicology, and safety strategy across small molecule and biologic products. Together, they bring over 45 years of combined FDA regulatory experience, having held senior leadership roles within CDER's Office of New Drugs. Their expertise spans carcinogenicity assessment, genotoxicity, nitrosamine impurities, and international harmonization of regulatory guidelines through active contributions to ICH Expert Working Groups. They support clients in designing scientifically robust and regulatorily sound nonclinical programs, leveraging deep knowledge of FDA policy, global regulatory expectations, and innovative safety assessment approaches, including the integration of new approach methodologies (NAMs).