U.S. Food and Drug Administration (FDA) compliance is fundamental to ensuring the safety, efficacy, and quality of food, drugs, medical devices, and cosmetics in the United States. It involves adhering to a complex framework of regulations and requirements established by the FDA to safeguard public health. Key aspects of FDA compliance include adhering to Good Manufacturing Practices (GMP), ensuring proper labeling and packaging of products, and submitting regulatory applications for approval before marketing regulated products. Additionally, companies must report adverse events and cooperate with FDA inspections and audits to demonstrate compliance.
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ISO certification is a globally acknowledged framework used to evaluate the management systems of companies on an international scale.
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