Tag: US FDA Agent services
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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 UEI Number Guide for Drug Establishments
Introduction For pharmaceutical companies planning to enter the United States market, compliance with the Food and Drug Administration is a legal requirement. One of the most critical compliance elements for foreign drug manufacturers is the appointment of an FDA U.S. Agent along with proper identification through the UEI number. Understanding how the FDA U.S. Agent…