PAI Audit Readiness Support & FDA Response Support

A Pre-Approval Inspection (PAI) by the FDA is essential to drug approval as well as the approval of new manufacturing partners. For FDA approved drugs being transferred or produced to a new manufacturing plant, Advantar Labs can provide customers with the support of pre-FDA audits to ensure quality systems are compliant and help to readily address outstanding last minute deficiencies.

Additionally, Advantar can provide representation to the FDA as area experts in your CMC process to assure adequate responses to inspection findings, including observations in Form 483, or address more serious operational matters involving a formal consent decree by the FDA.