Have you heard about the FDA's new electronic registration process? We have! If you are confused or would rather transfill and help your patients than spend hours setting up your computer- we can register for you. Call us and order OF-101. If you're in a hurry, we can even rush it for you (OF-101 RUSH). If you'd like to try to do it yourself, we are here to help. Read below to get started.
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.
If you would like to try it on your own, these steps will get you started.
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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.
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Set-up your Electronic Submissions Gateway Account. The FDA's Electronic Submission 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.
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Create the SPL in extensible mark-up language. 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 we can now register for you! Call us or
click here to order OF-101 for easy electronic registration.