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The understanding of the authorities' requirements is a prerequisite for correct execution of the specified guidelines.

FDA GMP Requirements

FDA does not need to be equivalent with a tedious inspection. 

Do you know the FDA requirements for production?
Are these consequently followed?
Do you know the difference with regard to the European Guidelines?
Do you have the right documents?

When you know the answers to those questions, then FDA readiness might be an important milestone for your company.

We support you in finding the right answers.