U.S. FDA Agent Services for Foreign Companies 

U.S. FDA Agent Services for Foreign Companies 

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of medical devices, drugs, food, and cosmetics intended for import into the United States must designate a United States agent (U.S. Agent). This U.S. Agent facilitates communication between the FDA and the foreign company. For more information about the annual U.S. Agent fee, please contact us.

About Us

At JIT CONSULTANCY, we provide reliable and cost-effective U.S. FDA agent services for foreign companies. It is crucial to appoint a U.S. Agent, as it is a mandatory requirement for foreign companies wishing to import their pharmaceuticals, medical devices, food, and cosmetics into the U.S.

First Importer Services for Medical Devices

We serve as the first importer for medical devices entering the United States. This service ensures that your products comply with U.S. customs regulations and FDA requirements, facilitating entry into the country. We minimize the challenges encountered during the import process and accelerate the market launch of your products.

FSVP Plan for the Food Industry

The Foreign Supplier Verification Program (FSVP) is a mandatory application by the FDA for companies importing food into the U.S. We ensure that our clients fully comply with all processes required under this program, thus guaranteeing food safety. FSVP planning monitors compliance with FDA standards at every stage of your supply chain.

FSVP Importer and Representative for Foreign Suppliers

We provide importer and representative services to foreign suppliers to meet FSVP requirements. These services include verifying that imported products comply with U.S. food safety standards. This allows businesses to confidently introduce their products to the U.S. market.

FDA Cosmetic Registration and Product Listing

We provide services for FDA registration and product listing necessary for the sale of cosmetic products in the U.S. market. These services are meticulously carried out to ensure compliance with legal regulations and consumer safety.

Transparent Service Approach with JIT CONSULTING

At JIT CONSULTING, we follow a transparent pricing policy and do not charge any hidden fees. If you have any questions about our services, do not hesitate to contact us directly. Our customer service team is ready to respond to your questions as quickly and clearly as possible.

Commitment to Customer Satisfaction

With a service philosophy that aims to exceed our clients' expectations, we offer a broad range of support from facility registration to label design review. Visit our website for detailed information about our services, contact details, and industry articles. You are always welcome to contact us to share your needs and suggestions. We look forward to collaborating and serving you!

FDA U.S. Representative

It is mandatory for foreign establishments to designate an FDA U.S. Representative for any product imported into the United States. This representative facilitates communication with the FDA from the production to the processing of the product. This representative service is crucial for foreign companies entering the U.S. market as all transactions with the FDA are conducted through this representative.

FDA Unified Registration and Listing System (FURLS)

FURLS is used to electronically submit representative information. Each foreign establishment can appoint only one FDA U.S. Representative, who can also serve as the official correspondent. Foreign establishments must provide the contact details (name, address, phone and fax numbers, email address) of their FDA U.S. Representative.

FDA U.S. Representative Approval Process

The appointed FDA U.S. Representative must officially confirm their acceptance of this role. This process begins with an email verification request from the FDA to the representative. The representative must agree to act as the contact person on behalf of the foreign establishment. If the FDA U.S. Representative does not confirm or respond within 10 business days, the establishment will need to appoint a new representative.

FDA U.S. Representative and Registration Services

Appointment of an FDA U.S. Representative is especially mandatory for products such as food to be sold in the U.S. market. This service includes the initial facility registration, updating any changes, and renewal processes. Additionally, the representative provides necessary documents to your business partners (suppliers, customers, and importers), notifies the FDA in advance, and inspects food product labels for compliance with FDA standards.

Biennial Food Facility Registration Renewal

According to the Federal Food, Drug, and Cosmetic Act, FDA-registered food facilities must renew their registrations every two years. This process begins on October 1st and ends on December 31st.

FDA Registration Number

Each registered food facility is assigned a registration number. This number does not imply FDA approval of the facility or product; it merely indicates that the FDA registration has been completed. Using this number on product labels to create the impression that it is FDA approved can be misleading.

Registration Certificate

The U.S. FDA does not provide a certificate after registration. However, at JIT CONSULTING, we issue a registration document to our clients after the registration process is completed. This certificate can be used to demonstrate active FDA registration on platforms such as Amazon. Additionally, FDA export certificates can be requested by businesses and governments outside the U.S. This certificate shows that the product is marketable in the U.S. and that the manufacturer is not facing any sanctions.

These expanded and detailed descriptions provide a more comprehensive understanding of the FDA U.S. Representative and related processes.

International Food Facility Registration and U.S. Agency Service ($1050)

This service includes FDA registration or necessary changes in existing registrations for your food facilities outside the U.S. Additionally, we provide continuous communication support through our agent in the U.S. for one year. This service package includes an electronic certificate for your registration and changes, and any changes or renewals during the service period are carried out free of charge.

Food Export Prior Notice Service ($450)

This service covers the mandatory prior notice submissions to the FDA before exporting food to the U.S. This notice allows the FDA to pre-assess the content and safety of your food shipment, making your export process smoother. This mandatory prior notice is a critical step to ensure that your export operations are not interrupted.

Food, Beverage, and Supplement Label Review ($450)

This service provides a detailed review of the labels of your food, beverage, and supplement products in accordance with FDA regulations. The review covers essential elements such as nutrition facts labels, claims on labels, ingredients, allergen statements, and product names. Since errors on labels can lead to FDA sanctions, this service helps identify and correct potential issues beforehand.

Food Canning Facility (FCE) and Process Filings ($4500)

Our service supports the FDA-required FCE registration and scheduled process filings (SIDs) for low-acid and acidified food products. This includes supporting all necessary processes for the FDA-compliant processing, packaging, and marketing of canned foods. An electronic certificate is provided for each application, and all changes made during the service period are carried out free of charge.

With these detailed and comprehensive services, we ensure that your food products are effectively and compliantly positioned in the U.S. market. If you have any questions or need more information, please do not hesitate to contact us

Responsibilities of a U.S. FDA Agent

  • Assisting the FDA in communicating with your company,
  • Responding to inquiries about your products imported into the U.S.,
  • Assisting the FDA in scheduling inspections of your facility,
  • Providing information to the U.S. Agent if the FDA cannot reach your company directly.

Who Should Consider Appointing a U.S. Agent?

  • Foreign facilities manufacturing medical devices, food, and drugs that wish to register with the FDA,
  • Foreign applicants for IND, NDA, and ANDA.

Why You Should Choose Our Company as Your U.S. FDA Local Agent?

✓ Professional

We offer U.S. FDA Agent services to our clients worldwide and possess an experienced team dedicated to providing professional regulatory consulting services.

✓ Confidential

It's important to note that the U.S. authorized agent is not a sales agent but a regulatory agent. Therefore, our company always performs our duties in a compliant manner and keeps critical information about your company fully confidential.

✓ Timely

The agent primarily plays a role in communication and liaison, representing you directly in communications with the FDA. Our company can respond quickly and effectively to any FDA inquiries and ensure smooth communication between you and the FDA.

Our company is committed to providing professional, cost-effective, and reliable agency services to effectively protect all legitimate interests of your company. If you need assistance or have any questions, please do not hesitate to contact us for more details.

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