"Performance driven healthcare solutions for next generation drug delivery!"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 development timelines and accelerate the movement of new products to worldwide commercialization.Key consulting Services including:Chemistry, Manufacturing and Controls (CMC)Pharmacology and ToxicologyClinical PharmacologyRegulatory 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 devicesAll WhiteOak documentations receive comprehensive QA reviews to ensure adherence to scientific and regulatory standardsFDA communications including US agent registration and representation