LIFE SCIENCES EXPORT

Certificates of Free Sale and Pharmaceutical Product Certificates, Authenticated

Registering a product abroad usually means authenticating the export certificates behind it: FDA certificates, Certificates of Free Sale, Certificates of Pharmaceutical Product and GMP documents. We handle the apostille or embassy legalization, alongside the corporate documents regulators also ask for.

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EXPORT CERTIFICATES

Ready for foreign regulators

Apostille or full embassy legalization.

FDA export certificates
State Certificates of Free Sale
GMP and manufacturing certificates
Corporate and letter-of-authorization packets

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How export certificates are authenticated

The path depends on who issued the certificate. Federal certificates, such as FDA export certificates, are authenticated at the federal level through the U.S. Department of State. State-issued certificates are apostilled by that state. Company documents, such as letters of authorization and declarations, are notarized first. For countries outside the Hague Convention, every document then goes through embassy legalization. We map the route for each document in your registration file.

Documents we authenticate

FDA Certificates to Foreign Government and Certificates of Exportability
Certificates of Pharmaceutical Product
State-issued Certificates of Free Sale
GMP and ISO certificates
Letters of authorization and declarations of conformity
Certificates of Good Standing and corporate documents

Requirements vary by country and regulator. Confirm the exact list with your regulatory team or local agent.

How it works

1
Send your document list
Your regulatory team's list for each country.
2
We map each document
Federal, state or company document, and Hague or non-Hague country.
3
Notarize, apostille, legalize
At your site in Greater Boston or by courier from anywhere in the U.S.
4
Delivered to your agent
Shipped to you or directly to your in-country representative.

Built for regulatory teams

Confidential handling

Your regulatory documents stay confidential.

How we handle a registration file

Regulatory teams send us the list of documents a foreign authority wants and the deadline. We sort each document by issuer: federal certificates, state certificates and company documents each follow their own path. Company documents are signed in front of a notary, at your office or with signers wherever they are. Then everything goes through the apostille or legalization route for the destination country, and arrives together.

Situations we handle often

A new market launch

Registration needs a full set of certificates and corporate documents at once.

A distributor change

New letters of authorization have to be notarized and legalized.

A license renewal

A foreign regulator asks for fresh certificates on a recurring schedule.

A non-Hague country

Every document needs embassy legalization after it's authenticated.

Mistakes we help you avoid

Treating every certificate the same. Federal and state certificates are authenticated by different offices.
Signatory mix-ups. Letters of authorization should be signed by the person named as signatory. We confirm before the signing.
Missing consular steps. Countries outside the Hague Convention need embassy legalization after state or federal authentication.
Expiring documents. Some regulators want recently issued certificates. We time the steps around your submission date.

Official sources

Hague Conference: list of Apostille Convention countries

We link to official sources so you can check the current rules yourself. Requirements change, and the receiving office always has the final word.

Built for regulatory deadlines

We work with life sciences companies in Boston and Cambridge on recurring registration filings. Tell us your submission date and we'll lay out the steps and timing for each document.

Why companies choose us for registration documents

Life sciences teams need documents that arrive correct and on time, because a rejected certificate can delay a launch. We know the difference between federal, state and company documents, we coordinate the federal and embassy steps through our DC Satellite Office, and we give regulatory teams one point of contact and an itemized invoice per matter. See Life Sciences.

Countries and regions we commonly prepare files for

Latin America

Brazil, Mexico, Colombia and others, often with translation.

The Middle East

The UAE, Saudi Arabia, Qatar and Kuwait, with embassy legalization.

Asia

China, Vietnam, Korea and others.

Europe

Apostilles for distributor and registration files.

Frequently asked questions

Can you authenticate FDA certificates?

Yes. Federal certificates are authenticated through the U.S. Department of State, then legalized at the embassy if required.

We need documents for several countries at once. Can you help?

Yes. We organize multi-country packets so each set follows the right route.

Can you come to our site to notarize?

Yes, anywhere in Greater Boston.

Do you handle translations for registrations?

Yes. See Certified Translation.

Can you work with our regulatory consultant abroad?

Yes. We coordinate with local agents and distributors.

Do you translate registration documents?

Yes, through our certified translation partners.

Do you handle documents for medical device companies?

Yes, including device export certificates and declarations of conformity.

Can you handle documents for several countries at once?

Yes. We map the route for each country and keep the files on one timeline.

Registering products abroad?

Send us your document list for each country.