Tag: FDA Agent registration
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FDA Drug U.S. Agent Services for Global Pharmaceutical Companies
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…
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FDA U.S. Agent Registration – Complete Guide for Foreign Companies
FDA U.S. Agent Registration is a mandatory requirement for foreign manufacturers, exporters, and facility owners who want to register their establishment with the U.S. Food and Drug Administration. Without appointing a U.S. Agent, a foreign company cannot complete or maintain its US FDA establishment registration. What Is an FDA U.S. Agent? An FDA U.S. Agent…