The Food and Drug Administration regulates all Food, Drugs, Medical devices, and cosmetics that are sold within the United States. This impacts the way who and how you can import products, and how those products must be labeled, manufactured, and registered.
FDA PRODUCT REGISTRATION
Failure to properly register facilities or products could lead to denial of entry of goods, fines, penalties, or seizure of goods.
We register FDA regulated products and facilities. We guide businesses through this arduous process with consideration of specific business and financial goals to deliver goods to the marketplace in a quick and cost-effective manner.
FDA PRODUCT REPORT
We provide in-depth compliance reports that review products in a holistic manner. We review all marketing statements, ingredients, labels, and packaging, to ensure a complete regulatory review.
FDA REGISTERED AGENTS
Foreign Entities shipping into the US market must have a U.S. resident to act as a registration agent on the Entities’ behalf.
The agent acts as a domestic contact for the FDA regarding questions or notices for shipments, technical inquires or transaction requests.
We provide full agent services that include registration and acting agent. As U.S agents we provide personalized one on one services during the import process.
PPE Personal Protective Equipment
PPE products must be registered with the FDA as well as their facilities. These products require specific labeling requirements and must meet applicable voluntary consensus standards that must be adhered to for successful import and selling in the market place. We have an expertise in registering new products and guiding companies in this niche market.