Registration of Company and Goods with the FDA

The FDA is the entry point not only to Amazon, but to selling to the USA market in general, both online and offline

When starting a business in the US market, sellers of certain product categories require registration with the FDA system. This is a standard that confirms that the quality of a product is safe for the consumer. However, many face a barrier: the complex individual registration process.

The Disqover team helps to make details of the procedure clear and provides consultation at all stages including the product and label audit, and the company or product registration.

FDA (Food and Drug Administration, FDA, USFDA) – an agency of the US Department of Health and Human Services that monitors compliance with laws and standards in certain industries.
FDA registration allows for:

The opportunity to import into the USA

FDA registration is mandatory for the import and sale of certain items on the US market, both online and offline

Competitive
advantage

An FDA inspection guarantees the quality of products and the seller’s reliability, as it involves checking for compliance with the largest number of safety criteria

High level of product and brand credibility

Company registration, as well as the presence of the FDA voluntary certificate of compliance, strengthens a company's image and loyalty to its products, increasing the demand for goods

Product categories requiring FDA registration

Our services

For producers of food, beverage and supplements
  • Audit of goods requiring certification
  • Label analysis to ensure compliance with the FDA requirements
  • Company registration
  • Obtaining a DUNS number
  • Filing a Prior Notice
For cosmetics
producers
  • Audit of goods requiring certification
  • Label analysis to ensure compliance with the FDA requirements
  • Company registration
  • Product registration
For OTC drug
manufacturers
  • Audit of goods requiring certification
  • Company registration
  • New Drug Application (NDA)
  • Form 2656 submission
  • SPL submission
For medical device
producers
  • Company registration
  • Premarket submission of FDA Form 510(k)
  • Submission SPL

Our cases

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