Starting June 1, 2009 the FDA stopped receiving paper submissions for registration. Registration must now be done electronically. (You can see the final guidance
here.) Setting up the electronic system may be confusing the first time, but the good news is that your registration will be available much more quickly.
Most firms are choosing to bypass the headache and have Applied register for them as a more cost effective answer. If you'd like to know a little bit about what is needed to register yourself, here is a very brief summary:
-
Obtain you DUNS number. A DUNS number is like a social security number for your business. The FDA will use it as a unique identifier to recognize your business and each of its locations. If you don’t already know your number, you can get it for free from the Dun and Bradstreet website
here.
Note: It’s best to use Internet Explorer for this website. You can get your DUNS number for free.
-
Set-up your Electronic Submissions Gateway Account. The
FDA’s Electronic Submissions Gateway (ESG) is where you will send your registration text file, once you create one. The steps you need to set up that account are
here. Setting up an account involves several steps and unlike most online registrations that you may be familiar with, will not be done in a few minutes. Be sure to start this process very soon.
-
Download the XForms Templates. Once you have gotten your ESG account, you will then need to create the files to send through the gateway to complete your registration.
Still Confused?? Don't worry Applied can register for you! Call us now and ask for Matt at (440) 788-4103 and get registered in as little as 24 hours.
Get more info on our service here.