FDA Document Apostille for Exporters
Documents signed by FDA officials are authenticated at federal level. We submit them to the U.S. Department of State and send your company the apostilled result as a PDF.
What this document is
Exporters of food, cosmetics, drugs and medical devices receive certificates from the FDA that foreign regulators rely on. Common examples are the Certificate to Foreign Government and the Certificate of a Pharmaceutical Product.
Where it is used
Importers and distributors in Spain and Portugal may need apostilled FDA certificates for product registration or regulatory dossiers. Requirements differ by product class, so ask your local partner what the regulator wants to see.
How to prepare it
- Provide the certificate exactly as issued by the FDA center.
- List the product names and any certificate reference numbers.
- Name the country and agency that will receive the certificate.
Check this first
Regulators often care about the certificate's own expiry date, which the apostille does not extend. If your dossier needs several sets, tell us at the start so each one can be authenticated.
How the apostille is obtained
- We review the issuing agency and what your receiving office requires.
- You send the document, unaltered and without notarization.
- We submit it to the Office of Authentications with Form DS-4194 and the $20 fee.
- The Department issues a paper apostille, and we email you a high-resolution PDF.
A common question
Does the apostille confirm our product is approved?
No. It confirms the signature or seal of the official on the certificate. What the certificate says about your product remains a matter between you, the FDA and the foreign regulator.