FDA Documents, Authenticated for Foreign Ministries.
End-to-end apostille and embassy legalization of FDA Certificates of Pharmaceutical Product (CPP), GMP certificates, Free Sale, drug master files, and clinical trial dossiers — hand-carried through the US Department of State by our Philadelphia firm.
Regulatory-grade document handling.
Built for pharma, biotech, and medical device regulatory affairs teams filing internationally.
USDOS Hand-Carry
FDA CPPs and GMP certificates walked through the US Department of State in DC — no mail-room delays.
Embassy Network
Direct desk relationships at UAE, Saudi, Egyptian, Chinese, and Russian embassies in DC.
Audit Trail
Every document logged, scanned, and tracked. Documentation provided for your DMF or eCTD submission.
NDA From Day One
Confidentiality agreements signed before any document is reviewed. Standard for pre-launch programs.
WHO-Format Aware
We know what Brazil ANVISA, Saudi SFDA, and UAE MOH actually require versus reject.
Sworn Translation
Spanish, Portuguese, French, Arabic — bundled before legalization so customs and ministries clear quickly.
Direct-to-Affiliate
DHL Express to your foreign affiliate, local MAH, or ministry of health.
Volume Pricing
Per-shipment pricing for manufacturers running 20+ CPPs or COAs per month.
Your pharmaceutical legalization, step by step.
A single firm runs the full chain from FDA verification to ministry filing.
Regulatory Intake
Regulatory affairs uploads the dossier through our secure portal. We verify FDA issuance, signatures, dates, and destination-country format before any document is moved.
- Secure portal
- FDA issuance verification
- Destination-format pre-check
USDOS Hand-Carry or State SOS
FDA-issued CPPs and GMP certificates are hand-carried through the US Department of State in DC. State-issued Free Sale certificates are routed to the issuing Secretary of State.
- USDOS hand-carry
- State SOS routing
- Tracked end-to-end
Mail submission to the US Department of State now runs 8–12 weeks. Our DC walk-in service typically returns federally apostilled CPPs in 5–10 business days.
Non-Hague Destinations
For non-Hague countries (UAE, Saudi Arabia, China, Egypt, Qatar) we route the package through the appropriate embassy in DC after USDOS authentication.
- UAE / Saudi / Egypt / China
- Embassy desk runners
- Status tracking by document
Sworn Translation Where Required
Spanish, Portuguese, French, Arabic, or Chinese sworn translation attached before legalization so the ministry receives a fully compliant dossier.
- Sworn or certified
- Bound with originals
- Ministry-grade formatting
DHL Express to Your Affiliate
Final package shipped DHL Express to your foreign affiliate, marketing authorization holder, or directly to the ministry of health. Tracking shared with regulatory affairs.
- DHL Express
- Direct-to-ministry option
- Final QC log
The most common mistakes we see.
Mailing CPPs to the US Department of State
USDOS mail processing is 8–12 weeks. Pharma timelines don't allow it. We hand-carry CPPs in DC for same-week turnaround.
Skipping embassy legalization for non-Hague markets
An apostille alone is not enough for UAE, Saudi, China, Egypt, or Qatar. The document must also be legalized at the destination embassy in DC.
Translating after legalization instead of before
Most ministries require the translation to be bound and authenticated together with the original. Translating after-the-fact triggers a second legalization cycle.
Philadelphia Notary & Apostille
We are a Philadelphia-based document legalization firm serving the pharmaceutical, biotech, and medical device industries. Located in the heart of the Philadelphia / New Jersey pharma corridor, we run end-to-end apostille, US Department of State authentication, and embassy legalization for regulatory affairs teams filing in Latin America, the Middle East, North Africa, and Asia.
Led by Brian Perez, our team coordinates directly with state Secretaries of State, the U.S. Department of State, foreign embassies, and sworn translators to deliver complete, ready-to-submit packages — reviewed before they ever leave our office in Chestnut Hill, Philadelphia.
Frequently asked questions
Filing a foreign drug registration?
Send us your CPP package and destination market — we'll quote the full legalization stack and start authenticated originals moving the same day.