We were asked for help in preparing a GCP inspection by the FDA.

The project lasted 1.5 months.

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This is how we did it:

  • Defined the strategy
  • Carried out several audits
  • Defined the answers to the gaps detected during 
the audits
  • Improved the quality system of the department according to the audit results
  • Weekly meetings with the client
  • Preparation and coordination the “back-room” before and during the inspection days