Introduction

We understand that getting your drug to patients is one of the most important and critical parts of your drug’s journey.

We’re with you every moment of your drug’s journey to approval—including evaluations, regulatory filing and maintenance support. TD2 manages the entire process for clients, from writing 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.

Diligence

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.

Planning

Both strategic and tactical planning is critical to a successful regulatory outcome. 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 drug development problem imaginable.

Execution

Your timelines are critical and they become TD2’s timelines. Work with a team 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. 

Ask us how you can get your regulatory assessment started today.