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Consulting Services

QRC consulting services assist our clients in preparing for FDA inspections (e.g. mock inspections), Pre-Approval, BLA, 510 (K), and PMA inspections.  Additional consulting services include providing problem solving and resolution of compliance and enforcement issues, as well as providing assistance to our clients in directing, managing, and responding to FDA correspondence and FDA inspectional observations (FDA 483 cites), and other enforcement actions.

Some consulting services include, but are not limited to the following:

  • FDA Inspectional Observations (FDA 483), Review, Evaluation and Response Preparation

  • Problem solving and resolution of FDA compliance and enforcement issue.

  • Training in cGMPs (drugs, devices, foods, biologic), DEA and Q7A.

  • Vendor/Supplier Qualification

  • Process and Facility Validation

  • CAPA Review, Evaluation, and Development

  • Quality Manual Review, Evaluation, and Development

  • Review, Evaluation, and Development of Standard Operating Procedures

  • Bio-Research Program, Review and Evaluation e.g. IND, NDA/ANDA, 510(k), and PMA

  • Change Control Program Review, Evaluation and Development




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