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SteelB

consultant help with FDA

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so i am still trying to get registered with the FDA. it has been pain staking process thus far. i was rejected on something and just had to re submit.

Going forward we have found a very good niche regionally. we wish to continue after the crisis is over. we also have high demand for gel sanitizer.

Is there anyone who can help with that approval process?

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20 minutes ago, SteelB said:

gel sanitizer.

Without knowing where you are in the process, I wonder if you are aware that you are not authorized to make gel sanitizer.  Gel sanitizer is specifically excluded from the FDA guidance.

https://americancraftspirits.org/wp-content/uploads/2017/02/Temporary-Policy-Compounding-Hand-Sanitizers-Revised-Guidance-Final-4-15-2020.pdf

 

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yes i am aware, we are not currently producing such.We do how ever have a great business opportunity, if i am able to produce the gel type sanitizer.

this is why i need to get this done as soon as possible. which is why i sought help from a consulting firm.

 

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how much are you blowing on the consultant? Is your expectation to receive an individual waiver?

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i do not want a waiver i am in the registration process now, after which i want to submit a formula for a gel version of the sanitizer.i will register using the who formula. but wish to add a gel to my my product line as we have a great opportunity in the region to produce and sell a gel based product.

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