Tag: What are the 5 categories of FDA?
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US Drug Registration Process: How to Register Drugs with the FDA
The United States pharmaceutical market is one of the most tightly regulated in the world. Any company planning to manufacture, export, or distribute drug products in the US must comply with US Drug Registration requirements enforced by the U.S. Food and Drug Administration (FDA). Without proper registration and listing, drugs cannot be legally sold or…
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Understanding the US FDA Drug Registration and Listing Database for Market Access
For pharmaceutical companies planning to sell drugs in the United States, compliance with the US FDA Drug Registration and Listing Database is not optional—it is a legal requirement. This database serves as the official record of drug establishments and products that are manufactured, processed, packed, or distributed for the US market. Every domestic and foreign…
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FDA US Agent for Drugs Complete Guide for Foreign Manufacturers
For pharmaceutical companies operating outside the United States, appointing an FDA US Agent for drugs is a mandatory regulatory requirement. The US FDA requires every foreign drug manufacturer, relabeler, repacker, and exporter to designate a US based agent who acts as the official communication link with the U.S. Food and Drug Administration. Without a properly…
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US FDA Certificate: A Practical Guide to FDA Registration, Verification & Compliance
By XPRO America – Global US FDA Consultancy Expanding into the United States market is a powerful growth move for any manufacturer or brand. However, before your products can legally enter the US supply chain, one requirement stands firm: US FDA compliance. Many businesses search for a “US FDA certificate” expecting a single downloadable document.…