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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...

Good Clinical Practice (GCP)  is the gold standard for conducting ethical and high-quality clinical research. In the era of decentralized...

In today's fast-paced world of clinical research, maintaining Good Practice (GxP) compliance is essential for ensuring the safety,...

Data integrity is no longer just a compliance checkbox—it’s a top priority  for regulators worldwide. The FDA, EMA, MHRA, and WHO  have...

Date: March 9, 2025 Welcome to our March deep dive into FDA inspections and the Radiopharmaceutical landscape! As these radioactive drugs...

Navigating Clinical Research Regulations: GCP Auditing Insights Clinical research is a critical component of advancing medical treatments...

In the pharmaceutical industry, adhering to Good Manufacturing Practice (GMP) GMP standards is essential for ensuring product quality...

When it comes to ensuring compliance with GxP standards in industries like pharmaceuticals and clinical research, having the right...