The WhiteOak Group

FULL-SERVICE REGULATORY CONSULTING The WhiteOak Group, LLC WhiteOak's regulatory and development strategies services are characterized by thorough understanding of the scientific, technical, and regulatory requirements, and attention to details. Providing comprehensive, integrated, efficient, and effective regulatory strategies to reduce developmen... t timelines and accelerate the movement of new products to worldwide commercialization. Regulatory Submissions: DMFs, INDs, 505b(2)NDAs, BLAs, and ANDAs inlucding Supplements, Amendments, Annual Reports, Safety Reports, and other regulatory documents for drugs, biologics and medical devices 1. Specialized in assisting pharmaceutical biotechnology, medical device companies, and academic organizations and foundations to obtain timely and cost-effective regulatory approval for their products. 2. WhiteOak's team are of senior former FDA reviewers, compliance officers, field inspectors that have an average of 20 years of industry experience in positions providing technical and regulatory support for the entire product development life cycle as well as investigational and marketing application submission preparation. 3. A long history of successful interactions with all regulatory divisions within FDA, including the Center for Drug Evaluation and Research (CDER), the Center for Biological Evaluation and Research (CBER), and the Center for Device and Radiological Health (CDRH).Read More