Export Certificates

Companies in regulated products often need help on the U.S.-side with export certificates when exporting to different countries. Whether you are importing product to re-process and then export, or you just need a certificate to satisfy your foreign counter-party, we are there for you.

Import-for-Export, Export Certificates, and Apostilles

Many companies import products into the United States to process or otherwise change them, before shipping them back out of the country. The difficulty is that such products, not intended for sale in the United States will not have the required labeling or even be legal for sale in the U.S.

The Food and Drug Administration (FDA) has a program called Import-for-Export (IFE) that allows companies to import products that do not comply with the law in this country, re-process them, and then export them without facing enforcement action.

The FDA, state governments and local Chambers of Commerce issue various kinds of export certificates.

The most common being a Certificate of Free Sale. These certificates assert that the product is legal for sale in the U.S. or at least that they are manufactured in the U.S. by an entity that is authorized to manufacture under FDA and/or state law. Foreign governments and customers often require these documents.

Also, many governments require that documents be further authenticated by a separate government authority. This is called an apostille. The apostille authenticates the signatures and seals, and then adds an official apostille seal.

An experienced attorney and team can help you successfully navigate foreign expert requirements for regulated products.

Types of Export Services
  • State Certificates of Free Sale
  • Apostilles
  • FDA IFE
  • FDA exporting unapproved drugs and devices
  • FDA export certificates (not an exhaustive list)
    • Certificate of Free Sale or Certificate of Export for Seafood
    • Certificate of Pharmaceutical Product
    • Certificate to Foreign Government
    • Certificate of Exportability
  • International Animal Product Export Regulations (IREGS)
  • Export Certificates: Animal and Plant Health Inspections Service (APHIS) and Agriculture Marketing Service (AMS)
  • Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) Permits (Fish & Wildlife & APHIS)
  • Free trade agreement analysis
  • Certificates of origin
How an FDA Attorney Can Help

An experienced attorney can help with not only selecting and obtaining the right permits but also help you comply with the myriad of related requirements.

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