Tag: FDA establishment registration guidance
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US Drug Establishment Registration: Regulatory Gateway to the US Pharmaceutical Market
Any facility that manufactures, processes, packs, or labels drug products for the United States must complete US Drug Establishment Registration. This regulatory obligation is enforced by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). US Drug Establishment Registration is a foundational compliance step. Without an active…
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FDA Drug Establishment Registration: Practical Compliance Guide
U.S. Food and Drug Administration drug establishment registration is a foundational regulatory step for pharmaceutical companies aiming to enter or continue operations in the United States market. Any facility involved in drug manufacturing or related activities must be properly registered to ensure transparency, safety, and regulatory control within the U.S. drug supply chain. What Does…
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US FDA Establishment Registration Database Compliance Services by XPRO America
Introduction For manufacturers, exporters, and brand owners targeting the United States, FDA compliance is not limited to product quality—it starts with accurate establishment registration. The US FDA Establishment Registration Database is the backbone of FDA oversight, import screening, and inspection planning. If your facility information is inaccurate, outdated, or improperly classified in the FDA database,…