Registration and Listing


  • Companies which import products serve for human and animal to the US must register with FDA before sell products to the customers. Some commodities must be listed all the information about manufacturer and the components. Foreign companies now can use online registration system to submit documents to the FDA. 

    The registration process is to make the company FDA account become validated to the FDA before any submission of listing or premarket approval documents. Each commodities has different requirements of registration and listing, some special products may be required annual user fee for the FDA account.

    In order to find all the corresponding information with the products, companies may spend a lot of time to research and still navigate the correct process. GOL US will simplify the job by performs these services regularly for all-sized companies that import food, medical device,… any other products that serve for human and animals.

     

  • Prior Notice

    After register an FDA account and receive approval for your products, FDA requires companies send a prior notice of importing these products for every shipments. These prior notice are required to report detail of the shipments accurately. The FDA will receive prior notice and approve for the shipments. Shipments which arrived at the U.S port without any prior notice will be stop and returned to the original destination. 

    Along with registration and listing service, GOL US provide the prior notice declaration service, which our staffs will contact the FDA to report about customers’ shipments. This service is required along with registration and listing service, customers must use both services. See the [PRICE CHART].  

  • U.S Agent

    The FDA states: “Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.”  This is a necessary regulations because during shipments may arise problems that need to solve and working with the FDA directly in the US. 

     

    US Agents are responsible to assist the FDA in communications with the foreign establishment (translation) any special requirement or information transaction. The agent will respond for any questions from the FDA about the products that are imported into the United State and assist in scheduling inspections of the foreign company. The FDA will work directly with the agent due to the difficulty in language may occur when working with foreign companies or unable to contact with the company directly or expeditiously.

    Due to the responsibilities are required of being an US agent, the person need to have ground knowledge and experiences in working with the FDA. And it is hard to find the right person for the job when not all companies are based in the United State. Therefore, GOL US provide the US Agent service for any company that demand a US legal representatives with well-knowledge and well-experience in the job and solving problems.

    Check the [PRICE CHART] for more information

  • Label Review & Design

    Label, website and advertisement are important tools to represent a company’s face. It is easily to get consumers trust when the presentations on these forms are beautiful and reliable. It is already hard to pull off impressive designs for a familiar market, it is even harder to design an outstanding label targeting for the new market which companies mostly don’t have the resource to research consumers taste.


    We support start-up and expanding companies to calculate the expense for labeling and marketing budget, as well as consulting them for how to use it effectively. Assisting exporters and global companies acknowledge of rules and regulations of their markets are included in our services. Market researchers spending years in the market will assist of information about customers taste and regulations of the government, the global marketing team in the other hand, will consult and proceed marketing and labeling projects in the most efficient way.
    The U.S market is one of the biggest market in the world, the also one of the most restricted market in regulations of marketing and labeling. The Foods and Drugs Administration (FDA) regulates the content and form of products required FDA approval, each commodity has different regulations about context printed on the labeling, and requirements about the content in marketing strategies. This is regulated all marketing platform including internet marketing sites. Any violation of labeling and marketing regulations could make the FDA targets the products, either seizes them or stop them from entering the U. S market.


    The manufacturer and distributor (importer) responsible for making sure required label information is easy to find, truthful and not misleading. And having a professional consultant who can quickly analyze and find the best solution for the marketing and labeling strategies is optimizing the budget. GOL US team are not only the consultant, we are also the people who can in charge of designing, labeling and marketing plans for your companies, our experts has been working on their majors for decades, and pleasant our customers primarily mission

  • Product Evaluation & Development

    Every product has different target customers and therefore, different marketing approaches to the market. The manufacturer and the seller are the most well-known person about their products. But, to evaluate the value and develop its advantage sometimes requires an objective eye to observe.

    Not only to meet the requirements of marketing method for target customers, products label and marketing strategies also need to meet the regulations of the government. Especially in the U.S market, the FDA is well aware of the power of words and virtual of the products, and to protect United State consumer, they have strictly regulations about labeling and marketing methods.

    GOL US represents to international exporters the product evaluation and development service, consult and assist companies to research target customers taste and comply with the FDA regulations. We show you the way to optimize your marketing budget and specify every step of the process.

    For more detailed information please [CONTACT]