FDA Registration Services

Fast and reliable FDA registration and US agent services for non-US companies entering the US market.

Helping non-US companies navigate FDA registration for successful US market entry.

We provide FDA Food Facility Registration and US Agent Service to non-US companies. Our import export services include an FDA Registration service that helps small businesses register their facilities with the FDA. Our service is intended to support your first step in obtaining the necessary documents to import your product and enter the US market. We act as your US Agent to register your facility with the FDA. Our service is fast, reliable. We work closely on each specific case to help you best achieve your goals.

Why should you choose us?

Acting as your US agent to facilitate FDA registration and compliance.
Swift and reliable FDA registration tailored to your specific business needs.
Fast Registration Process
Import export support: Comprehensive support for your import and export needs in the US market.

Overview of FDA Registration

The U.S. Food and Drug Administration (FDA) is responsible for regulating a wide range of products, including food, pharmaceuticals, medical devices, and cosmetics. For foreign manufacturers wishing to export their products to the United States, registering with the FDA is a crucial step. This registration process ensures that products meet U.S. safety standards and regulations.

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Understanding FDA Registration Requirements

Foreign facilities that manufacture or process food for consumption in the U.S. must register with the FDA under the Bioterrorism Act of 2002.

The registration must be renewed every two years, and facilities must provide updated information regarding their operations.

Role of a U.S. Agent:

The FDA requires foreign entities to designate a U.S. agent who can act on their behalf in communications with the FDA.

This agent must reside or maintain a physical presence in the United States and is responsible for receiving communications from the FDA regarding inspections or compliance issues.

Steps to Register Your Facility:

Gather necessary information about your facility, including its name, address, type of business operations, and contact details.

Complete the registration process through the FDA’s online system known as FURLS (Food Facility Registration Module).

Pay any applicable fees associated with registration.

Importance of Compliance:

Non-compliance with FDA regulations can lead to significant consequences, including product detentions at ports of entry, fines, or even bans on selling products in the U.S.

It is essential for businesses to stay informed about changes in regulations and ensure ongoing compliance.

Import Broker Services:

In addition to assisting with FDA registration, our services extend to acting as a U.S. Import Broker:

Facilitating Imports:

As an import broker, we help navigate complex customs regulations and ensure that all documentation is correctly completed for smooth importation.

We assist in classifying goods according to tariff codes and ensuring compliance with all federal regulations.

Logistics Management:

Our team coordinates logistics from shipping arrangements to delivery at your specified location within the U.S., simplifying the entire import process for small businesses.

Export Services:

We also provide support for exporting products from the U.S. to other countries by ensuring compliance with international trade laws and regulations.

Our export services include documentation preparation, customs clearance assistance, and logistics management tailored to each destination country’s requirements.

Conclusion

By utilizing our comprehensive services for FDA registration and acting as your U.S. Import Broker, we aim to simplify your entry into the U.S. market while ensuring compliance with all regulatory requirements.

Our FDA Registration and US Agent Services

Our import and export services include an FDA Registration service designed to assist small businesses in registering their facilities with the FDA. This service is intended to support your initial steps in obtaining the necessary documentation to import your products and enter the U.S. market. We act as your U.S. Agent to facilitate the registration of your facility with the FDA. Our service is fast and reliable, and we work closely on each specific case to help you achieve your goals effectively. Please contact us for assistance with your needs.

Food and Beverage Services: The FDA registration service for food and beverage includes essential components for non-U.S. food facilities. This service ensures compliance with U.S. regulations, which is crucial for foreign entities wishing to export food products to the United States. Key offerings include:

Non-U.S. Food Facility Registration and US Agent Service: This involves registering foreign food facilities with the FDA and designating a U.S. agent who can act on behalf of the facility in communications with the FDA.

Prior Notice Filing: Before importing food into the U.S., prior notice must be filed with the FDA, detailing information about the shipment, including its contents and origin.

Food Registration & US Agent Renewal: Regular renewal of registrations is necessary to maintain compliance, ensuring that all information remains current and accurate.

Medical Device Services: For medical devices, our services focus on ensuring that manufacturers comply with FDA regulations regarding their products:

Medical Device FDA Agent Annually: This service provides an annual appointment of a U.S. agent for foreign medical device manufacturers, facilitating communication with the FDA.

Device Listings: Manufacturers must list their devices with the FDA before marketing them in the U.S., which involves providing detailed information about each device.

Global Unique Device Identification Database (GUDID) Submission: Manufacturers are required to submit device identification data to GUDID, which helps track devices throughout their lifecycle.

Drug Establishment Services: Our drug establishment services ensure compliance for pharmaceutical companies:

FDA Drug Registration: This involves registering establishments that manufacture or distribute drugs in the U.S., ensuring they meet regulatory standards.

Registrant Contact and US Agent Annually: Similar to other sectors, an annual appointment of a U.S. agent is necessary for effective communication with regulatory bodies.

Drug Listings: All drugs must be listed with the FDA before they can be marketed, requiring detailed submissions about each product.

Medical Device Label Review: Ensuring that labels meet FDA requirements is critical for both safety and compliance.

Cosmetics Services: For cosmetics, our services help ensure that products meet safety standards:

Cosmetic Registration: While not mandatory like other categories, registering cosmetics can facilitate smoother market entry by demonstrating compliance with safety regulations.

Cosmetic Registration & US Agent Renewal: Regular updates and renewals are essential to maintain registration status and ensure ongoing compliance.

Dietary Supplements Services: Similar to food services, dietary supplements require specific registration processes:

Non-U.S. Food Facility Registration and US Agent Service: This mirrors food facility registration but focuses specifically on dietary supplements.

Prior Notice Filing & Food Registration & US Agent Renewal: These processes are similar to those outlined in food services, emphasizing compliance for dietary supplements entering the U.S. market.

DUNS Registration Filing Services: DUNS (Data Universal Numbering System) registration is vital for businesses seeking credibility in international trade: Standard & Expedite Filings: We offer support services for both standard and expedited DUNS filings, helping businesses establish their identity in global markets efficiently.

Trademark Registration with the US Patent and Trademark Office: Registering a trademark is essential for protecting a name or brand from theft or misuse of intellectual property as a business expands. We offer services to assist you in initiating the trademark registration process with the United States Patent and Trademark Office (USPTO). While applications can be completed relatively quickly, the entire registration process may take several months due to various factors such as examination by the USPTO and potential opposition from third parties. Our services include securing your trademarks and patents, submitting an initial TEAS (Trademark Electronic Application System) standard application for each class of goods or services, and maintaining your registration. This maintenance involves submitting declarations of use and/or non-use with valid reasons, as well as applications for renewal when necessary.

In summary, our comprehensive range of services across various sectors ensures that non-U.S. entities can navigate complex regulatory landscapes effectively while maintaining compliance with FDA requirements.

Your Trusted FDA Registration Partner

We facilitate FDA registration for non-US companies, ensuring a smooth entry into the US market with reliable and fast services tailored to your specific needs.