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Tag: What is a US agent in FDA?

  • FDA Drug U.S. Agent Services for Global Pharmaceutical Companies

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    For pharmaceutical manufacturers operating outside the United States, appointing an FDA Drug U.S. Agent is a compulsory step under US FDA regulations. Without a designated U.S. Agent, foreign drug establishments cannot complete US FDA Drug Establishment Registration or legally supply drug products to the U.S. market. The U.S. Agent acts as the official liaison between…

  • FDA US Agent for Drugs: Complete Guide for Global Manufacturers

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    For pharmaceutical companies located outside the United States, appointing an FDA US Agent for drugs is not optional—it is a mandatory regulatory requirement. The US FDA requires every foreign drug manufacturer, repacker, relabeler, and exporter to designate a US-based agent who acts as the official communication bridge between the company and the U.S. Food and…