Regulatory success. By design.
TD2 is an oncology CRO that cares about your success as much as you do. Our team can navigate the entire lifecycle of your therapy’s journey from concept to market ensuring it meets the standards of any regulatory agency. By handling the entire regulatory process including pre-IND planning and meetings, Investigational New Drug (IND) applications and maintenance, specialty filings and more, we work tirelessly to get your treatment to patients and ultimately approved.
A customized approach to regulatory strategy.
There is no one-size-fits-all approach to regulatory strategy, but with diligent planning and scientific research, we are able to identify unique regulatory opportunities as well as risks that could delay your development program. Chemistry, Manufacturing and Controls (CMC) is a critical path activity that requires careful planning and execution, and we have an expert team to help navigate those challenges. In addition, our Pharmacology and Toxicology experts have decades of experience with small molecules, large molecules and biologics. Close communication keeps your timelines on track moving your therapy forward, faster.