US FDA Agent Services

We provide US FDA Agent Services across the Globe. The United States Food and Drug Administration (USFDA) enforces the need for foreign-based Food, Drug, and Medical Device companies without a location in the United States to register with the FDA after appointing an FDA US Agent.

Our FDA Consulting Firm is committed to helping clients by complying with FDA registration requirements and maintaining records throughout the tenure. US FDA Agent must be a resident of the USA or maintain a place of business in the USA and will be the primary point of contact between the manufacturer and FDA.

US FDA Agent Services

Our FDA Agent services are designed for all foreign clients located outside the United States.

Food / Nutraceutical / Dietary / Ayurveda

We are US FDA Agent and helping companies register their Food facilities with US FDA

Under the Federal Food, Drug, and Cosmetics Act, U.S. and foreign food facilities engaged in the manufacturing, processing, packing, or holding of foods for consumption in the United States are required to register with the FDA. Registered foreign food facilities must also have a U.S. Agent who acts as a liaison with the FDA.

The goal of this guidance document is to inform you that the FDA has established a U.S. Agent Voluntary Identification System (VIS) to work in tandem with our food facility registration database, the Food Facility Registration Module (FFRM). The VIS’s purpose is to ensure the accuracy of US FDA agent information and to allow US agents to independently identify the facility or facilities for which they have agreed to serve. This guide provides information for U.S. agents and foreign facilities that choose to use the VIS when importing food into the United States.

Medical Device

Agent for the United States Registrants of foreign establishments subject to this part must appoint a single US agent. The United States agent must reside or maintain a place of business in the United States, which cannot be a mailbox, answering machine, or service, or any other location where the United States agent is not physically present. The United States agent is in charge of:

Read More from FDA Website.

Pharmaceuticals

We are medical device regulatory consultants and US FDA Agents helping manufacturers and Exporters across the globe to register and List the products with US FDA.

We provide FDA Agent services for the following category of Products

  • OTC Drugs [ Those Drug molecules listed in the OTC monograph are only considered]
  • API Manufactures [ all kinds of pharma API’s included]
  • Homeopathic [ All kinds of homoeopathic medicines]
  • Testing Laboratories [ Laboratories testing OTC and Generic Drug products for Human and Clinical trial purposes]
  • Medicated Lotions, Creams and other external preparation [ considered as cosmetics in various countries]

Cosmetics Facility

Cosmetics are not subject to FDA for mandatory establishment registration or Listing. It is the firm’s responsibility to assure that its cosmetic products and ingredients are safe and properly labelled in full compliance with the US FDA regulations before marketing in the USA.

As per US FDA regulation, any cosmetics formulated increases its effectiveness or action with the help of an active medical compound. It should be considered as a Drug. The regulation is different and you need to follow that regulation.

Manufacturers or Distributors not falling in this category can follow the link to complete Voluntary Cosmetic Registration Program (VCRP).

US FDA Agent Services for Food & Dietary Supplements

We are US FDA Agent to help companies register their Food facilities with US FDA.

Under the Federal Food, Drug, and Cosmetics Act, U.S. and foreign food facilities engaged in the manufacturing, processing, packing, or holding foods for consumption in the United States are required to register with the FDA. Registered foreign food facilities must also have a U.S. Agent who acts as a liaison with the FDA.

The goal of this guidance document is to inform you that the FDA has established a U.S. Agent Voluntary Identification System (VIS) to work in tandem with our food facility registration database, the Food Facility Registration Module (FFRM).

The VIS’s purpose is to ensure the accuracy of US FDA Agent information and to allow U.S. agents to independently identify the facility or facilities for which they have agreed to serve. This guide provides information for US agents and foreign facilities that use the VIS when importing food into the United States.

US FDA Agent for Medical Device

Agent for the United States Registrants of foreign establishments subject to this part must appoint a single US FDA agent. The United States agent must reside or maintain a place of business in the United States, which cannot be a mailbox, answering machine, or service, or any other location where the United States agent is not physically present. The United States agent is in charge of :

US FDA Agent for Drug Establishments

We are consultants and US FDA Agents helping manufacturers and Exporters across the globe to register and List the products with US FDA.

We provide service for the following category of Products

  • OTC Drugs [ Those Drug molecules listed in the OTC monograph are only considered]
  • API Manufactures [ all kinds of pharma API’s included]
  • Homeopathic [ All kinds of homoeopathic medicines]
  • Testing Laboratories [ Laboratories testing OTC and Generic Drug products for Human and Clinical trial purposes]
  • Medicated Lotions, Creams and other external preparation [ considered as cosmetics in various countries]

US FDA Agent for VCRP Registration

Cosmetics are not subject to US FDA for mandatory establishment registration or Listing. It is the firm’s responsibility to assure that its cosmetic products and ingredients are safe and properly labelled in full compliance with the US FDA regulations before marketing in the USA.

As per USFDA regulation, any cosmetics formulated increases their effectiveness or action with the help of an active medical compound. It should be considered as a Drug. The regulation is different and you need to follow that regulation.

Manufacturers or Distributors not falling in this category can follow the link to complete Voluntary Cosmetic Registration Program (VCRP).