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consultant help with FDA


SteelB

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we are currently attempting to register with the FDA as we have been producing sanitizer under the covid guidelines. I have been at it for a few days now.

i hope to be able to complete that in the next day or so . as long as i don t do anything else wrong to get rejected. so firstly i would need help getting that done if i am unsuccessful 

Secondly we have a tremendous opportunity within our region if we can make a gel sanitizer. We are looking for a consulting firm that may be able to help us get that worked out as quickly as possible.

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2 hours ago, SteelB said:

i hope to be able to complete that in the next day or so . as long as i don t do anything else wrong to get rejected. so firstly i would need help getting that done if i am unsuccessful 

We've been through the process as have others on this forum.  From my perspective it is a 3 step process, register your company, register your company as a labeler and register your product.  Send a screen print of where you are getting rejected and maybe I can get you going again.  As I previously wrote, the instructions must be followed very closely or you will get rejected.  From what I saw, the rejections did a pretty good job of guiding you to the error. 

Are you following the Product Listing - Hand Sanitizer in the lower left corner?

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I m currently waiting for them to get back to me. so i may have been able to get registered . we ll see. beyond that though i am still looking for recommendations for consultants to get the new gel formula through the fda.

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On 5/27/2020 at 9:05 AM, SteelB said:

I m currently waiting for them to get back to me. so i may have been able to get registered . we ll see. beyond that though i am still looking for recommendations for consultants to get the new gel formula through the fda.

There is no waiver allowing you to manufacture gel sanitizers. You are only approved to make WHO (liquid topical hand sanitizing solution 80%).


Cheers,

NBM

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yes i understand there is no waiver for gel. i am attempting to get registered and ammend the who formula or submit a new formula. to be able to produce a gel sanitizer as i have a tremendous business opportunity if i can secure that

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