TD2 provides a broad range of regulatory and compliance expertise with comprehensive project management to ensure that your novel compounds meet U.S. Food and Drug Administration (FDA) standards and move swiftly into clinical development.
Our regulatory team is comprised of physicians, scientists, project managers and regulatory experts with extensive experience in FDA regulations, pre-Investigational New Drug (IND) application and IND strategies, IND submissions, and FDA regulated trials. We specialize in addressing the unique hurdles confronted by each program. Services include consulting in: Chemistry, Manufacturing, and Controls (CMC); Good Laboratory Practices (GLP); Toxicology/Pharmacology Support Services. We also perform IND-related services and other regulatory filings.
Our emphasis on strategy, writing and compliance is based on a commitment to the success of our clients' transition into the clinic and ultimately the treatment of patients.