Audit Readiness of BE Study Documentation: Ensuring Regulatory Compliance
Regulatory inspections of bioequivalence (BE) studies are routine but critical, especially when submitted as part of ANDA filings or global marketing authorizations. Agencies like CDSCO (India), FDA (USA), and EMA (EU) expect complete, traceable, and GCP-compliant documentation. Audit readiness ensures not only compliance but also protects the sponsor’s reputation and timelines.
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