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Biotech is one of the most regulated fields in life sciences. Every process, from early development to large-scale manufacturing, must follow strict quality and safety standards. Falling short can lead to regulatory holds, product recalls, or reputational damage. This is why GxP compliance services play such a critical role for biotech companies. Understanding GxP in Biotech “GxP” stands for “Good [x] Practice.” Depending on the stage of work, it can refer to: GMP (Good Manuf

Running a pharmaceutical company comes with complex responsibilities. Every decision, from raw material sourcing to product distribution, is monitored under strict regulatory standards. A single documentation error or incomplete investigation can draw unwanted attention from regulators and lead to costly consequences. The safeguard against these risks is a strong Quality Management System (QMS). At GxP Auditing and Consulting Services, we work with pharmaceutical organization

If you want to know whether a manufacturing site is GMP-compliant, don’t start with the lab— start with the batch records. These...

In today’s regulated environment, a vendor audit  is more than just a compliance obligation—it's a critical part of protecting your...