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Pre-Approval Inspection Readiness (PAI Audits)

As companies move to this stage in the drug process, it becomes imperative to gather all of the pertinent information in anticipation of an NDA or ANDA filing and be organized and prepared. USDM has the depth and breadth of experience in this area, having conducted many PAI Readiness audits. Our team includes an ex-FDA employee who conducts several of our assessments and audits in this area. We know what you should have and what the agencies will be looking for!

Examples include Drug Master File comparison with CMC Master File where the DMF comparison with the CMC Master File compares critical aspects to assure parity between the two documents prior to review by regulatory bodies. For example, residual solvent in API after at final release characteristics are compared as well as peak resolution between co-eluants.

Another example includes Technology Transfer where the transfer between R&D and Production operations must have completely well-matched equipment and operations which match the DMF and NDA/ANDA faithfully which was submitted in regulatory filings to the MHRA and FDA, for example, for pre-licensing readiness.

Other examples include:

  • Site Master Files & Master Validation Plans
  • MHRA, FDA & DEA facility pre-licensing readiness assessments