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+1-703-517-5612
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Arlington, VA 22201
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US Apostille and Legalization
We can get your documents apostilled and legalized on your behalf by the appropriate government authorities according to the requirements of various markets.
US Apostille and Legalization of Documents
Many government authorities outside the US recognize the validity of documents issued by US government authorities such as FDA only if they are apostilled or legalized by the appropriate government authorities. Therefore, they will require you to have some of the device registration document apostilled or legalized.
An apostille is for documents you use in countries in the 1961 Hague Convention Treaty. Authentication certificates are for documents you use in countries not in the 1961 Hague Convention Treaty. Once the documents have been authenticated, they still need to be legalized by either the consulate or embassy of the destination country to be valid for use in the another country. Apostilled documents do not need to be legalized and can be directly used in the destination country.
US Apostille and Legalization of Documents
Many government authorities outside the US recognize the validity of documents issued by US government authorities such as FDA only if they are apostilled or legalized by the appropriate government authorities. Therefore, they will require you to have some of the device registration document apostilled or legalized.
An apostille is for documents you use in countries in the 1961 Hague Convention Treaty. Authentication certificates are for documents you use in countries not in the 1961 Hague Convention Treaty. Once the documents have been authenticated, they still need to be legalized by either the consulate or embassy of the destination country to be valid for use in the another country. Apostilled documents do not need to be legalized and can be directly used in the destination country.
US Apostille and Legalization Process
The US Department of State (DOS) issues apostilles or authentication certificates for documents issued by government authorities at the federal, state, or local level. However, depending on the document and the issuing body, the requirements can differ. For example, CFG issued by US FDA might need to be notarized by a notary public in the local county or state before being sent to DOS along with a request form to receive apostille certificate. In the case where the destination country is not a member of 1961 Hague Convention, the same CFG might need to be locally notarized, authenticated by the Secretary of the Local State, authenticated by the DOS, and finally legalized by the Consulate of destination country located in the US. Often, the process can be complex and long, overwhelming for especially foreign companies.
Pineprep has the expertise and resources to get your US document notarized, certified with apostille or authentication, or legalized on your behalf. Our team has vast experience with navigating the complex landscape of regulatory challenges and will provide guidance.
We offer a diverse range of regulatory services.
Our services are focused on assisting medical device and IVD companies achieve regulatory and standard compliance.
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We are committed to providing the highest quality services for our clients.