Tag: What is a US agent in FDA?
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FDA Drug U.S. Agent – Complete Guide for Pharmaceutical Companies
For any pharmaceutical company located outside the United States, appointing an FDA Drug U.S. Agent is a mandatory requirement before registering with the United States Food and Drug Administration. Whether you manufacture finished dosage forms, active pharmaceutical ingredients, or engage in drug packaging or labeling, a U.S. Agent acts as the official communication bridge between…
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FDA US Agent for Drugs Complete Guide for Foreign Manufacturers
For pharmaceutical companies operating outside the United States, appointing an FDA US Agent for drugs is a mandatory regulatory requirement. The US FDA requires every foreign drug manufacturer, relabeler, repacker, and exporter to designate a US based agent who acts as the official communication link with the U.S. Food and Drug Administration. Without a properly…