GxP Best Practices Part 1: Outsourced Operations
September 16, 2024
In this 4 part series, we are talking through GxP Best practices This
In this 4 part series, we are talking through GxP Best practices This
In the realm of clinical research oversight, adherence to regulatory standards is not
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring
Maintaining a regulatory compliance strategy is crucial for any company’s sustainability and success
Based on my recent discussions with clients and industry stakeholders, the consequences of
Our practice lead, Teresa Gorecki, recently shared her LinkedIn article that addresses new
In a new development for global pharmaceutical regulation, the FDA and the European
Why do good manufacturing operations have inadequate FDA inspections? FDA warning letters and
There are no FDA regulations governing writing quality or clarity. FDA Investigators will never
Preventing batch failures and protecting your business is crucial to success within the
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