In the life sciences industry, patient safety is non-negotiable. Whether you’re developing pharmaceuticals, biologics, or medical devices, establishing a robust pharmacovigilance (PV) and safety...

In the life sciences industry, your products are only as reliable as the partners you depend on. Whether you’re sourcing raw materials, reagents, packaging components, or contract manufacturing and...

Medical device and diagnostic manufacturers face increasingly complex regulatory landscapes — especially when bringing products to both the United States and the European Union. While the U.S. FDA...

What Is Risk-Based Quality Management (RBQM), and How Is It Applied? Risk-Based Quality Management (RBQM) has become one of the most transformative approaches in modern clinical research and quality...

Clinical trials are the backbone of medical innovation. They provide the evidence regulators need to determine whether a drug, biologic, or device is safe and effective for patients. But designing...

What Is an FDA 483? An FDA Form 483 is issued at the conclusion of an inspection when an investigator observes conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act or related...