Compliance Consultants does not leave you guessing about
our cost for a 510(k) submission. Compliance Consultants has
done so many 510k' s we do not "learn on your nickel" like
some regulatory affairs consultants - who charge by the hour.
We have done so many 510K submissions that we know what
is required once your product and claims are explained.
We recommend that you bring us "on-board" early in the project. Our fee does not increase regardless of the time (6 months or 18 months)- but the project will be easier for both of us.
We are successful because we do the hard work to create "good science". We work hard and charge you for that work. But, we are not expensive. We propose a charge and honor it! Our fixed-fee does not change - providing you do not change the project after we quote you.
You might notice real experts always charge fixed fees. Amateurs charge time and materials because they must protect themselves from risks they cannot anticipate. We know the risks.
We recommend that you bring us "on-board" early in the project. Our fee does not increase regardless of the time (6 months or 18 months)- but the project will be easier for both of us.
We are successful because we do the hard work to create "good science". We work hard and charge you for that work. But, we are not expensive. We propose a charge and honor it! Our fixed-fee does not change - providing you do not change the project after we quote you.
You might notice real experts always charge fixed fees. Amateurs charge time and materials because they must protect themselves from risks they cannot anticipate. We know the risks.
Our fixed-fee is simple, ½ the fee to start and ½ the fee when we submit your application to the FDA. This fee includes all requests for "Additional Information" that the FDA may require as part of their review.
