Benefits To Appoint US FDA Agent FDApals

FDApals provide US FDA Agent Service that is full solution for helping you navigate the complex and confusing FDA process. We will help you with all aspects of your product, from initial marketing strategy to regulatory compliance. Our agents are trained professionals who have years of experience working with the FDA, and we will guide you through every step of the process so you can focus on what you do best: running your business.

We understand how important it is to stay compliant with FDA regulations, which is why we offer our services at an affordable rate. We also have several packages available so that you can choose the one that suits your needs best. Whether you need help with just one product or multiple products, we have a solution tailored to fit your budget and needs.

We have been helping small businesses get FDA approval for over 30 years. Our founder, Mr.Rajkuamr Gupta, started this company because he was frustrated by how difficult it was to get FDA approval as a small business owner. He knew that people like him needed help navigating the complicated process of getting approval, so he created us: The FDA Agent Service!

We are a team of dedicated professionals who work hard to make sure our clients get their products approved quickly and easily so they can focus on what matters most to their business.

Our team has decades of experience working with both small and large food companies, so we know how to tailor our services so that they're right for you. Whether you're looking for FDA OTC Registration, Facility Registration or QMS implementation we have the resources available to make sure that everyone gets what they need from our services.

We work with clients from all over the world—from  USACanada Mexico down through Central America and South America, as well as throughout Europe and Asia.

Our unique US FDA Agent service provides you with the answers to all your questions about the FDA approval process. Not only do we employ experts who have worked at the FDA themselves, but we also have access to a wealth of information that will help you better understand how your product can meet compliance standards. We offer consulting services for companies that want to develop new products for sale within the United States market but are unsure of how this process works.

US FDA Agent Responsibilities:

The US FDA Agent must have a place of business in USA or be residing in USA. One cannot use an answering machine or virtual office for US Agent. It is expected that either the agent or his/her employee is available to answer the phone during working hours.

  1. The US FDA Agent acts as a bridge and connect the establishment with FDA thy facilitate communication between them.
  2. US FDA Agent has to answer the queries raised by the FDA with respect to the products (food, cosmetics, devices, drugs etc.) that are imported in USA.
  3. They assist the FDA in scheduling Inspection of foreign establishments.
  4. IF FDA is not able to connect to Establishment designated contact person, they may provide information or document to their US Agent and this will be considered equivalent to giving information/document to foreign establishments
  5. US FDA Agent can also submit documents and make application on behalf of the foreign establishments or domestic establishments to FDA for marketing authorization or facility registration.
  6. There are more general responsibilities of US FDA Agent
    1. Should provide latest updates from FDA with respect to regulation which can impact their business
    2. Issue US FDA Certificate for Registration of establishments
    3. Annual and Biannual Renewal of establishments.
    4. Update FDA with any changes in establishments.
    5. Handling request for FEI number/ Duns Number

If you're interested in learning more about how we can help your business comply with FDA regulations while still meeting its goals, contact us today!

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