Preapproval Inspection (PAI) Assistance

It starts with a well managed inspection. Inspectors expect that the applicants understand and demonstrate FDA regulations through documented evidence, personnel interaction and site visit. What is more effective than having an external organization perform a mock inspection?
At PSC, we have former FDA employees with extensive auditing experience and employees who are capable to do just that. In addition we could:

  • Deliver an effective briefing of PAI flow
  • Give insights to escorts (inspection coordinators) and Subject Matter Experts (SME) on how to face the inspectors appropriately
  • Assist in preparation of Quality System documents and records of products for inspection
  • Give tips on DOs and DON’Ts during the inspection

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