We understand that getting your drug to patients is one of the most important and critical steps in oncology drug development.
We’re with you every moment of your drug’s journey to approval—including regulatory affairs consulting, program evaluation and management, strategy, regulatory filings and IND maintenance support. TD2 manages the entire regulatory process for clients, from writing for pre-IND and IND submissions to completing paperwork and everything in between, ensuring that your compounds meet U.S. Food and Drug Administration (FDA) standards and can move swiftly into clinical development.
This is a key step to TD2’s ability to inform the decision making process, identify regulatory and operational risks, and create the foundation for success.
Both strategic and tactical planning is critical to a successful regulatory strategy. Oncology drug development is a series of problems that need to be solved. Set your drug up for success by working with a team that has not only seen, but tackled every oncology drug development problem imaginable.
When you’re involved in drug development, your timelines are critical and they become TD2’s timelines. Work with an oncology CRO that will challenge you every day to keep your timelines on track, that has the vision for your drug’s success, and knows what to do every day to help you reach your goals.