Legal · FDA · Translation Services for Healthcare and Pharma
Thailand is the medical-tourism capital of Asia and a regional clinical-trial hub. Healthcare operators navigate the Thai FDA, MOPH licensing, CIOMS clinical-trial rules and tight cross-border patient-data requirements. NYC Legal & Notary Services delivers the medical-grade translation and legalisation chain regulators and hospitals require.
Challenges this sector faces
Thai FDA registration
Drugs, devices, cosmetics and food supplements each have separate FDA pathways with multilingual technical dossiers.
Clinical-trial document chains
Investigator brochures, protocols and ICFs must be translated to Thai with sworn certification before ethics-committee submission.
Medical-tourism patient packs
International patients need translated/legalised medical records and visa extensions; insurers demand certified document chains for reimbursement.
Foreign physician credentialing
Medical Council of Thailand requires translated and legalised diplomas, residency certificates and disciplinary letters.
How NYC Legal helps
FDA dossier translation
Sworn TH translation of CMC, stability and clinical sections, plus MFA legalisation of certificates of origin and GMP statements.
Clinical-trial document chain
End-to-end translation and notarisation of trial documents per CIOMS / ICH-GCP.
Medical-tourism patient support
Visa extensions, certified medical-record translation and embassy-ready insurance documentation.
Key regulations
- Drug Act B.E. 2510 (amended)
- Medical Device Act
- Cosmetic Act
- Medical Profession Act
- Personal Data Protection Act (PDPA)
- ICH-GCP / CIOMS guidelines
Typical documents
- Certificate of Pharmaceutical Product (CPP)
- GMP / ISO 13485 certificate
- Clinical-trial protocol & ICF
- Investigator CV & diploma
- Patient medical records
- Health insurance documents
Our process
Regulatory gap analysis
Map product or service to FDA/MOPH requirements.
Translate & certify
Sworn TH translation by medical SMEs.
MFA + embassy
Legalise foreign certificates for FDA submission.
Submission
File with Thai FDA / MOPH / Medical Council and follow up.
Case study
- Problem
- Required Thai FDA registration with CMC and clinical dossier translated within 30 days.
- Solution
- 5-translator medical team + parallel MFA chain + FDA liaison.
- Outcome
- Registration approved on first submission; product on Thai market 14 days ahead of plan.
FAQ
Q. Do you handle Thai FDA Class III device applications?
Yes, including clinical evaluation and post-market surveillance documentation.
Q. Can you support multi-site clinical trials?
Yes — we coordinate document chains across hospitals nationwide.
Q. Patient-record translation for insurance claims?
Yes — certified EN↔TH translation accepted by major insurers.
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Talk to a specialist
Send your scope via LINE or email; we reply with a fixed quote and timeline within 15 minutes during business hours.