Tag: FDA US agent responsibilities
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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…
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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…
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FDA US Agent for Drugs: Complete Guide for Global Manufacturers
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…