Tag: US FDA Agent services
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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 U.S. Agent UEI Number Explained for Foreign Drug Companies
Introduction Entering the United States pharmaceutical market requires more than product quality and manufacturing capability. Regulatory compliance with the Food and Drug Administration is mandatory for every foreign drug establishment. One of the most important compliance requirements is appointing an FDA U.S. Agent and completing registration using a valid UEI number. Many companies struggle to…