FDA Pre-Approval Readiness

After many years of hard work, and coordination between different departments and outsourcing activities, you submitted your application to the FDA for approval. How you can ensure a positive outcome to the FDA pre-approval visit?

There are many factors you need to ensure that they are in place to get the positive outcome of this long awaited visit, for example:

  • What is the overall state of your facility’s cGMP compliance?
  • Have you compiled your regulatory documents in a way that make them audit friendly?
  • Have you identified and reviewed your key batch records?
  • Do you have a clear track record of your analytical methods, and their transfer protocols?
  • Have you reviewed you analytical raw data?
  • Have you written your development report?
  • What is the state of control of your equipment, validation, SOPs, records, material, production, process, corrective and preventive actions?

Of course, there are many other questions that you need to have the right answer for, before the FDA shows up at your door.

Don’t leave anything to chance. Let Synergy Bioscience shine the light of compliance on your quality system by preparing your facility for a successful Pre-Approval Inspections (PAI).