Investigational New Drug ( IND ) Registration with US FDA
To conduct clinical studies in USA, you need to submit an Investigational Device Exemption (IDE) to the Food and Drug Administration or FDA and receive their approval.
How can GRP Help you with your IDE?
As your partner in USA, GRP will do the following for you:
Step 1- we will define the classification and the risk of your device
Step 2- we will identify if your device requires an IDE or not.
Step 3- we will compile the IDE for you, if
your device requires an IDE application
Step 4- We will Submit your IDE Application to the FDA
Step 5- We will respond to FDA queries during the IDE review
Step 6- We will receive FDA approval for your IDE
Step 7- We will help you start your clinical study in the USA with your new medical device