Checklist for Contractual Agreements with CROs in Stability Testing
✅ Introduction: Why a Detailed Contract is Crucial in Stability Outsourcing In the pharmaceutical industry, outsourcing stability studies to Contract Research Organizations (CROs) or contract labs is a common practice to optimize resources and leverage specialized infrastructure. However, this comes with inherent compliance risks. Regulatory agencies like CDSCO and EMA emphasize the need for clear,…
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