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PAI (Pre-Approval Inspection)

Be prepared!
You want to introduce a new product and have to make sure that your production site is compliant with GMP-requirements and FDA-standards?

Good preparation is the key to successfully passing a "Pre-Approval"-Inspection. Paramount to success is to know the expectations of the FDA, to provide a clear and comprehensible documentation and to thoroughly plan the day of the inspection. We check your Quality Assurance System as well as your production plant and we define identify and name the shortcomings.

We advise, prepare protocols and checklists, we train your staff with regard to 21CFR part 210/211 and part 820, we perform mock-audits and take care of organizational issues Through our efficient project management, you will be able to cope with all preparatory measures thus approaching a PAI being optimally prepared.