IND Services

Pre-IND Activities:

TD2's Regulatory Team excels in evaluating our clients' needs, understanding how to craft questions to the FDA, preparing the Pre-IND Meeting Request, Pre-IND Information Package, and attendance at the Pre-IND Meeting or Teleconference.

Investigational New Drug (IND) Application Activities:

TD2 can fully support all activities related to the IND Application and IND submission. Services include:

IND Maintenance:

TD2 can also be responsible for supporting IND maintenance once the IND has cleared FDA review. TD2 can act as the primary contact with the FDA, and maintenance activities include the following: