The United States Food & Drug Administration (FDA) requires establishments that manufacture, process, package, or store food, drugs, and medical devices marketed in the United States to register with the FDA. Additionally, drug and device manufacturers must register their products with the FDA. This US FDA registration must be completed annually to comply with US FDA regulations.

If you are new to the United States market, the level of regulation and oversight can be quite complex. It's a lot easier to be compliant from the start than it is to try and fix mistakes after they've already happened. We provide advice on the formats, elements and details required for filing FDA registrations such as whether any registration exemptions apply.

We help you prepare and submit your registrations to the FDA, and track updates, changes, and cancellations to achieve full compliance. This may include determining whether any user fees for registration are necessary or ensuring the correct Issuance of Certificates for Registration.

These certificates can help protect your data and give US customers confidence that you have received the required registration.

Under the Bioterrorism Act, foreign manufacturers of drugs and devices must disclose the identity of known US importers. Upon importation, a declaration must be sent to the FDA specifying the registration numbers of the various firms in the supply chain.

What if you don't register?

Failure to register is a prohibited act under U.S. Federal Food, Drug, & Cosmetic laws and may result in the following consequences:

•The federal government can take civil and criminal measures against you

•Your cargo will not be allowed to the United States. Your products will be held at the port of entry and you are fully responsible for the organization and payment of all storage, transportation, and posting of bonds.

At Willow Glen Consultancy LLC , we help send Prior Notices and work closely with your Customs broker to ensure Bioterrorism compliance and Prior Notice. We will also act as the U.S. agent for overseas establishments.

We understand the complexities of FDA registration and compliance. We strive to provide consulting services to meet manufacturers and distributors' needs of a wide range of products, including medical devices, cosmetics, pharmaceuticals, nutritional supplements, and foods. Whether you need help obtaining the required license and certifications as a foreign manufacturer, or need an extra pair of eyes to review your labels and documentation for compliance issues, our legal advice can be of paramount importance in streamlining your business and resolving potential issues early on.

Our knowledge of how to deal with rules and compliance issues can help you enter the market faster by reducing the risk of U.S. administrators derailing you. When you've worked hard to develop a product, you want to make sure that your product is available to the people as soon as possible.

Get in touch with our offices today for a personalized approach to your rules and compliance issues.

Author's Bio: 

Willow Willow Glen Consultancy LLC is a firm providing registration, compliance assistance, and U.S. Agent Services for the food and beverage, cosmetics, and medical device industries.