In today’s global marketplace, compliance with international regulations is essential for businesses exporting pharmaceuticals, medical devices, cosmetics, and other FDA-regulated products. Among the critical documents required to facilitate international trade is the Certificate of Exportability. To ensure that this certificate is accepted abroad, it must be properly authenticated and, in many cases, apostilled. CFG Apostille specializes in providing professional support for obtaining and authenticating Certificates of Exportability, helping businesses expand globally with confidence.

What is a Certificate of Exportability?

A Certificate of Exportability is an official document issued by the U.S. Food and Drug Administration (FDA). This certificate authorizes the export of FDA-regulated products that may not have approval for domestic distribution within the United States but meet the standards of the importing country.

The document verifies that:

  • The product is manufactured in an FDA-registered facility.
  • The product complies with the safety and quality standards required by the importing country.
  • The product is legally eligible for export under U.S. regulations.

The Certificate of Exportability is essential for businesses that manufacture products intended solely for foreign markets. It reassures foreign regulators, importers, and distributors that the product meets necessary standards despite its restricted status in the United States.

Apostille and Legalization of a Certificate of Exportability

While the FDA issues the Certificate of Exportability, many foreign authorities require additional validation before accepting it. For countries that are members of the Hague Apostille Convention, an apostille is required to authenticate the certificate. For non-member countries, embassy or consular legalization may be necessary.

This step confirms the authenticity of the FDA’s signature and seal on the document, ensuring that it will be legally recognized abroad. Without this validation, businesses risk costly delays or outright rejection of their export certificates.

How CFG Apostille Assists with Certificates of Exportability

CFG Apostille provides expert services for securing and authenticating Certificates of Exportability, ensuring compliance with international documentation requirements. Their professional approach reduces administrative burdens and eliminates uncertainty for exporters.

Services Offered by CFG Apostille:

  • Document Authentication: Verification and processing of Certificates of Exportability for apostille or embassy legalization.
  • Expedited Services: Fast-track options for businesses with urgent export deadlines.
  • Global Acceptance: Ensuring documentation is properly validated for use in Hague Convention and non-Hague Convention countries.
  • End-to-End Support: Guidance throughout the entire process, from document preparation to final delivery.

Benefits of Partnering with CFG Apostille

Exporters who work with CFG Apostille gain significant advantages, including:

  • Specialized Knowledge: Expertise in handling FDA-issued documents like the Certificate of Exportability ensures accuracy and compliance.
  • Time Efficiency: Expedited processing avoids delays that can impact international shipments.
  • Cost-Effectiveness: Professional handling reduces the risk of errors that could result in additional fees or rejected documents.
  • Reliable Compliance: Apostilled or legalized certificates are universally recognized, ensuring smooth acceptance abroad.
  • Peace of Mind: With CFG Apostille’s support, businesses can focus on growth and operations instead of documentation challenges.

Secure Your Certificate of Exportability with CFG Apostille

Global trade in FDA-regulated products requires strict compliance with both U.S. and foreign regulations. A Certificate of Exportability is a vital document for businesses aiming to expand internationally, and ensuring its authentication through apostille or embassy legalization is essential for acceptance abroad.

CFG Apostille offers the expertise, efficiency, and reliability needed to secure your certificates with confidence. Whether you are exporting pharmaceuticals, medical devices, or cosmetics, CFG Apostille ensures that your documents are processed promptly and recognized worldwide.

CFG documents received online

Simply upload your CFG digital file, you will receive by FedEx your document processed with an apostille.

Processing time

  • expedited service
  • No need to ship your document.
  • Billing is available.
  • Credit card payment is OK.
  • US Department of State fee is included.
  • No need for the US Dept. of State form.
  • Track your history and spending online.

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