Tag: How to get US FDA license in India?
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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 U.S. Agent Requirement for Foreign Pharmaceutical Manufacturers
For foreign pharmaceutical companies planning to manufacture, export, or supply drugs to the United States, appointing an FDA Drug U.S. Agent is a mandatory regulatory obligation. The U.S. Agent serves as the official representative of the foreign drug establishment and acts as the primary communication channel with the United States Food and Drug Administration. Without…
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US FDA Consultants: Strategic Regulatory Partners for Global Businesses
Entering the United States market is a major opportunity for manufacturers and exporters, but it also comes with strict regulatory responsibilities. Products regulated by the U.S. Food and Drug Administration must meet detailed compliance standards before they can be legally marketed. For many companies, especially those operating outside the US, navigating these requirements without expert…
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US FDA Drug Registration Consultant – Global Regulatory Expertise for Pharmaceutical Market Access
Entering the United States pharmaceutical market is not simply an expansion decision—it is a regulatory commitment governed by the U.S. Food and Drug Administration (US FDA). Every drug product marketed in the United States must comply with strict standards related to safety, efficacy, quality, labeling, and manufacturing practices. Because the US FDA regulatory framework is…