How to Register with the FDA
K2A Management is an FDA consultant in Cambodia. We help Cambodian clients register their products with the FDA and helps companies comply with U.S. Food and Drug Administration (FDA) regulations quickly and properly.
Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This process is done in conjunction with the human drug registration process.
FDA Guidance Documents
Guidance documents describe FDA’s interpretation of FDA policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. FDA guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies.
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