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iBio Consulting
GxP Compliance and Readiness
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GMP assessments: Evaluate lab operations for compliance with relevant GxP standards depending on the study phase (nonclinical, clinical, commercial).
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Mock inspections: Conduct FDA/EMA-style audits to assess readiness and identify corrective/preventive actions (CAPAs).
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Inspection support: Help labs prepare for, navigate, and respond to health authority inspections.
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