Regulatory translation services, audit-ready from the first word

Regulatory translation is the translation of content that a regulator, court, or auditor will review, or that a law requires in the local language. Examples include clinical trial documents, medical device labeling and instructions for use, regulatory submissions, legal filings, and financial disclosures. Beyond accuracy, it needs controlled terminology, documented qualifications, independent revision, and records that show how each translation was produced.

ISO 17100 is the international standard for translation services. It sets qualification requirements for translators and revisers, requires every translation to be revised by a second qualified person, and requires documented processes from project preparation to delivery. Our certification is audited by an independent certification body.

The FDA does not approve or certify translators. Where FDA regulations or guidance call for translations, they generally expect complete and accurate English translations produced under written procedures, and the sponsor remains responsible for them. Our workflow is built to give you that evidence: qualified linguists, independent revision, and records for every step.

Under the EU Medical Device Regulation, labels, instructions for use, and other information supplied with a device must be in the official language or languages required by each Member State where the device is made available. Requirements vary by country and by user group, so check the current Member State requirements. We translate into every official EU language.

Linguistic validation shows that a translated questionnaire, such as a patient-reported outcome measure, measures the same thing as the original. It typically includes forward translation, reconciliation, back-translation by an independent linguist, review, and testing with patients. Sponsors often require back-translation for consent forms and other high-risk patient materials.

For most regulated content, we recommend professional human translation with independent revision. Machine translation with full post-editing by qualified linguists can suit high-volume, lower-risk material, such as internal reference documents. We advise on the right approach for each content type and never use machine translation on your content without your approval.

We build and maintain an approved glossary and translation memory for each program, using your reference materials and your reviewers’ decisions. Every linguist on the program works from the same approved terms, so the protocol, consent forms, labeling, and reports stay consistent.

No. The U.S. Department of Health and Human Services does not recognize any HIPAA certification for vendors. What matters is the safeguards a provider applies to protected health information. We protect confidential and personal data under our ISO/IEC 27001 certified information security management system, and we sign a Business Associate Agreement with covered entities.

Files move through secure transfer, access is limited to the people working on your project, and everyone involved is bound by confidentiality agreements. Our information security management system is certified to ISO/IEC 27001 and audited independently.

Ask for current ISO certificates and the scope they cover, the vendor’s translator qualification criteria, evidence of independent revision, information security policies, confidentiality agreements, and a completed supplier questionnaire. We provide a supplier qualification pack and welcome supplier audits.