Regulatory Translation Services for Compliance-Critical Documents

GTS Translation excels at providing specialized regulatory translation services for documents that must comply with laws, technical standards, and oversight by government agencies and industry regulators. Our translations are accurate, traceable, and delivered under our ISO 17100-certified quality system, making them suitable for audits, submissions, approvals, and compliance workflows.

Industries that Require Regulatory Translation Services

Here are some of the industries that we serve, each having a requirement for regulatory translation services.This includes:

• Pharmaceuticals and life sciences
• Medical devices
• Healthcare
• Chemicals and Manufacturing
• Energy, aviation, and engineering
• Financial services and corporate compliance
• Government, import/export, and trade
• Food and Beverage Industry and labeling compliance

Recognized as a Leading Provider of Regulatory Translation Services

AI translation company Milengo ranks GTS Translation among the best regulatory translation companies in the industry, highlighting our proven expertise and long-standing track record in delivering compliance-ready translations for global organizations.

Your Go-To Resource for Regulatory Translations

Regulatory translation services generally cover these documents:

• Medical, pharmaceutical, and clinical trial documentation (e.g., IFUs, PILs, SmPCs, clinical trial protocols, ethics submissions)
• Safety Data Sheets (SDS) and chemical compliance documents (REACH, CLP, WHMIS, OSHA, GHS)
• Technical and manufacturing compliance files (CE Marking, ISO documentation, conformity declarations, QA manuals)
• Legal and financial regulatory filings (corporate disclosures, public filings, compliance statements, audit reports)
• Government applications, import/export certifications, permits, and standards-related records

Why use GTS Translation for Your Regulatory Translations?

• ISO 17100-certified workflows with documented QA and full traceability
• Subject-matter expert translators in medical, legal, technical, and scientific domains
• Terminology consistency aligned with industry standards and controlled vocabularies
• Confidential and secure handling of sensitive regulatory documents
• Audit-ready deliverables suitable for inspections, approvals, and compliance reviews

Whether you’re submitting documentation to a regulatory authority, supporting a product launch in new markets, or preparing compliance materials for internal or external review, GTS ensures translations that regulators — and your quality system — can rely on.

Regulatory Translation Case Studies

Here are some recent projects that we have done:

• Chinese to English translation of a 2,000 page toxicology for Arbutus Biopharma
• Italian to English translation of a PCT medical device patent application for Elisa Plastic Surgery
• Italian to English translation of annual reports for Eataly
• English to Chinese translation of Hague Service Convention litigation package for Greenberg Traurig LLP
• English into Japanese of Safety Data Sheets (SDS) for Allresist, a German manufacturer of semiconductor photoresist materials

Frequently Asked Questions About Regulatory Translation Services

What are regulatory translation services?

Regulatory translation services cover documents that must comply with laws, technical standards, quality systems, or government and industry requirements. Examples include medical device IFUs, pharmaceutical documentation, Safety Data
Sheets, toxicology reports, clinical trial materials, CE Marking files, financial disclosures, audit reports, import/export documents, and regulatory submissions.

Why is regulatory document translation different from general translation?

Regulatory document translation requires controlled terminology, while preserving mandatory warnings and codes, and maintaining consistency with previously approved documentation. Errors in compliance-critical translations can delay product approvals, audits, market entry, customs clearance, or legal proceedings.

Does GTS provide ISO 17100-certified regulatory translation services?

Yes. GTS Translation provides regulatory translation services under an ISO 17100-certified quality system. Our workflow includes qualified translators, documented quality assurance, terminology management, review procedures, and traceability suitable for compliance reviews, audits, regulatory submissions, and product approval workflows.

Do you provide regulatory translation services for medical devices?

Yes. We translate medical device Instructions for Use, user manuals, labels, packaging, software interfaces, risk management documentation, technical files, declarations of conformity, clinical evaluation materials, and other compliance-critical medical device documents. Our medical device IFU translation services support manufacturers launching and maintaining products in international markets.

Can you translate pharmaceutical regulatory documents and clinical trial materials?

Yes. Our pharmaceutical regulatory translation services include clinical trial protocols, informed consent forms, investigator brochures, patient information leaflets, summaries of product characteristics, ethics committee submissions, toxicology documentation, pharmacovigilance materials, and other life sciences documents requiring accurate and consistent medical terminology.

Do you provide Safety Data Sheet translation services for REACH, CLP, GHS, OSHA, and WHMIS compliance?

Yes. GTS provides Safety Data Sheet translation services for chemical manufacturers and exporters in all languages. We work with SDS documents governed by GHS, REACH, CLP, OSHA HazCom, and WHMIS requirements. Our translators preserve hazard classifications, CAS numbers, signal words, precautionary statements, exposure controls, and standardized chemical terminology.

Do you translate CE Marking and technical compliance documentation?

Yes. GTS translates CE Marking documentation, declarations of conformity, technical construction files, ISO documentation, quality manuals, standard operating procedures, validation records, testing documentation, and manufacturing compliance files. These translations can support audits, conformity assessments, product registration, and international market access.

Do you provide financial regulatory translation services?

Yes. Our financial regulatory translation services include annual reports, quarterly reports, corporate disclosures, audit reports, investor communications, risk disclosures, compliance statements, ESG reports, and governance documents. We use translation memories and controlled financial terminology to maintain consistency across recurring reporting periods.

Do you translate import, export, sanctions, AML, and KYC compliance documents?

Yes. We translate import/export documentation, customs records, sanctions compliance materials, export-control documentation, supplier due diligence materials, beneficial ownership records, AML and KYC documentation, PEP screening
content, and third-party risk management documents.

Can you translate food and beverage labeling compliance documents?

Yes. GTS provides food and beverage regulatory translation services for ingredient lists, allergen statements, nutrition information, packaging text, product specifications, safety documentation, and labeling content intended for international markets. Terminology and mandatory statements are handled in accordance with the requirements provided for the destination market.

How do you maintain terminology consistency in recurring regulatory translations?

We use translation memories, approved glossaries, previous translations, controlled vocabularies, and client-specific terminology instructions. This is particularly valuable for recurring IFU updates, quarterly financial reports, revised Safety
Data Sheets, technical manuals, and product documentation in which only part of the content changes from one version to the next.

Are your regulatory translations suitable for audits and regulatory submissions?

Our regulatory translations are prepared using documented ISO 17100-certified workflows and can be delivered with the traceability and quality controls required for audits, inspections, internal compliance review, product approvals, and
regulatory submissions. The exact acceptance requirements should always be confirmed with the receiving authority or notified body.

How can I request a quote for a compliance-critical document translation?

Upload the source files through the GTS Translation online quote system and specify the required languages, deadline, target market, regulatory framework, and any approved terminology or previous translations. We will review the documents and
provide pricing, turnaround time, and recommended quality-assurance steps.