License to Operate (LTO) Application Goes Electronic
Now you can apply for a LTO from Food and Drug Administration in the comfort of your own home. Thru the use of an electronic portal (e-portal), you can submit an LTO application and wait for the approved LTO to be mailed to your designated address.
Access to E-portal
Everyone is required to have a valid User Account in order to access the e-portal. This may be easily acquired thru sending an email to FDA with information pertaining to the company as well as a scanned authorization letter from the company itself.
Electronic LTO Procedure
Navigating the e-portal is as easy as filling up forms and uploading documents just like in any social media platform. Once you have an User Account, you will be enabled to electronically submit the documents required for a LTO application. E-portal accepts new, renewal and variation applications.
This process replaces the Integrated Application Form (IAF) which must be submitted personally in the authorized FDA Centers. Once approved, you just have to wait for the mailing of your LTO.
FDA could not give a definite schedule yet on how this new process will change the processing period of LTO applications but they assure that it will definitely cut off a lot of time.
You may contact Triple i Consulting for any inquiries regarding product registration. Our pharma division has an extensive track record in representing some of the largest pharmaceuticals and food and beverages companies in the world.