Mock Inspection Consulting Project for a Clinical-Stage Biopharmaceutical Company

As the GCP landscape continually evolves, sponsors are encouraged to pursue innovative approaches. Mock Inspections are a critical tool to ensure inspection readiness and a quality control step to confirm that the innovative approaches are being implemented in a regulatorily compliant way. Inspection Readiness needs to keep pace with this philosophy and to be proactive, risk-based, and agile.

A mid-sized clinical-stage biopharmaceutical company intended to submit a Biologics License Application (BLA) mid-year in 2019. The company requested that Avoca conduct a 4-day on-site Mock Inspection with a regulatory agency focus on the FDA.

Because the company was a member of the Avoca Quality Consortium (AQC), Avoca’s project team leveraged AQC leading practices, where applicable.

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