Investigational New Drug ( IND ) Registration with US FDA
The FDA requires that a drug be the subject of an approved marketing application before it is transported or distributed across the US-state lines. This Application is known as an Investigational New Drug (IND). The IND is the means through which the sponsor technically obtains this exemption from the FDA.
For your IND, Global Regulatory Partners can perform the following activities for you:
Step 1: Perform a gap analysis
Step 2: Define the regulatory strategy for your IND application
Step 3: Prepare and Compile your IND application
Step 4: Publish and submit your IND application to FDA