Tag: What is required for FDA registration?
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U.S. Agent Voluntary Identification System (VIS) – A Critical Step for Stronger USFDA Communication & Compliance
Foreign manufacturers exporting regulated products to the United States must interact with the United States Food and Drug Administration (USFDA) through multiple electronic systems and regulatory processes. One important component of this framework is the U.S. Agent Voluntary Identification System (VIS). The VIS program allows U.S. Agents and foreign establishments to voluntarily provide additional identification…
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US FDA Cosmetic Registration Process: Step-by-Step Compliance Roadmap for Cosmetic Companies
The regulatory environment for cosmetics in the United States has undergone a major transformation with the implementation of the Modernization of Cosmetics Regulation Act (MoCRA). One of the most important outcomes of MoCRA is the establishment of a mandatory cosmetic registration process enforced by the US FDA. Today, cosmetic registration is no longer a voluntary…
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FDA Drug Establishment Registration: Guide for Global Pharmaceutical Companies
U.S. Food and Drug Administration drug establishment registration is a mandatory regulatory requirement for any company involved in manufacturing, processing, repacking, relabeling, or distributing drugs intended for the United States market. Whether you are a domestic manufacturer or an overseas pharmaceutical company, proper FDA registration is the first compliance step before your products can legally…