Written Translation / Translation for Regulated Companies
Translation Services for Regulated Companies
Avoid compliance issues with accurate translations for regulated industries from The Language Doctors—trusted by many federal agencies and Fortune 500 companies for over 25 years.
200+ languages
25 Years of Reliable Regulated Industry Translations
Having translated content for many regulated companies, we understand that the smallest translation error can have significant consequences. Our specialized regulatory translation services ensure your content meets stringent regulatory standards while effectively reaching a global audience. For over 25 years, The Language Doctors have helped regulated companies communicate clearly and comply with international standards by adapting content for diverse languages and cultures.
Why Choose The Language Doctors?
The Language Doctors (TLD) is a multi-certified organization trusted by regulated industries worldwide. We are an ISO 17100-certified translation company and HIPAA compliant, ensuring you get the highest quality and security standards.
The Language Doctors have over 2,000 translators with native language expertise in over 200 languages. We only hire accredited translators from leading US organizations, including the American Translators Association (ATA), the Institute of Translation and Interpreting (ITI), and the National Association of Judiciary Interpreters and Translators (NAJIT).
Expertise in regulatory translation services
We understand the stringent requirements of regulated sectors. Our team knows that accuracy, compliance, and precision are non-negotiable. We ensure every translation meets industry-specific regulations, providing peace of mind for our clients
Legal and compliance translations
Our services include accurate translations for legal contracts, compliance documents, and regulatory submissions.
Our translators are language and legal domain experts, ensuring translated content complies with local and international laws, minimizing the risk of misinterpretation, and ensuring regulatory compliance.
Understanding of industry-specific terminology
We understand industries such as pharmaceuticals, finance, healthcare, and legal services have specialized terminology. We ensure that this jargon is accurately translated and consistently applied across all materials, maintaining the integrity and clarity of your communications.
Meeting regulatory deadlines
Regulated companies often face strict deadlines for submitting documents to authorities. We provide timely and efficient regulatory document translation services to meet these deadlines without compromising quality or accuracy. We are known for our commitment to deadlines and the fastest turnarounds in the industry.
Confidentiality and security
We handle sensitive and confidential information with the utmost care. Our strict confidentiality and security protocols protect your data throughout the translation process. We are HIPAA-compliant and ISO-certified and comply with international regulations, including GDPR, SEC, CCPA, and FINRA.
Case Studies
How EPPA Fixed Interpretation Gaps
Fighting with Interpreter Shortage at the University Cancer & Blood Center (UCBC)
Case Study: U.S. Fish and Wildlife Reach a Global Audience | TLD
Frequently Asked Questions
It means our translations are not only accurate but are produced through a documented, ISO-certified quality management system that provides a clear audit trail to withstand scrutiny from regulatory bodies like the FDA.
We protect your sensitive data through strict, HIPAA-compliant security protocols and end-to-end encryption. All our linguists are bound by non-disclosure agreements, ensuring your intellectual property remains secure throughout the translation process.
Yes, we provide certified translations that include a formal Certificate of Accuracy. This signed statement attests to the completeness and precision of the translation, serving as official documentation for regulatory bodies and audits.
Our translators for pharma translation projects are accredited by organizations like ATA and ITI. They possess subject-matter expertise in pharmaceuticals and are required to have extensive experience in translating clinical trial documents, regulatory submissions, and medical device manuals.
Being ISO 17100 certified means our translation processes meet the highest international standards for quality. This includes requirements for professional translator qualifications, a separate review by a second linguist, and robust project management procedures.
Industry-Specific Translation Services for Regulated Companies
Clinical trial translations
We provide accurate translations for a wide range of clinical trial documents, ensuring compliance with regulatory standards across all phases of research. Our regulatory translation services guarantee that your clinical documents meet all necessary guidelines.
Translations for US regulatory agencies
Our expert team specializes in regulatory translations for major agencies, including the FDA, EMA, NMPA, and PMDA. We ensure your documents comply with the stringent standards of these regulatory bodies, providing accurate and reliable translations for all your regulatory needs.
Drug labeling and validation
From primary to tertiary labels for investigational drugs, we ensure your labels meet international and FDA requirements. Our meticulous process guarantees compliance and accuracy every step of the way, safeguarding your products and patients through professional language translation for regulatory affairs.
Technical translation services
Our technical translation services help you maintain regulatory compliance and effectively communicate complex information and instructions across different languages, including product datasheets, technical specifications, research papers and technical articles, maintenance manuals, and engineering documents, to name a few.
Financial reports
Our experts combine native fluency with deep financial knowledge to deliver accurate and consistent translations, supporting your financial reporting and compliance needs.
Medical devices translation
We translate essential documents such as Instructions For Use (IFUs), user guides, and technical manuals for medical devices. Our translations ensure user safety and compliance with global regulations, helping you meet market entry requirements with translations for regulatory documents.
Electronic Clinical Outcome Assessments (ECOA)
ECOAs are crucial for the regulatory process. Our expert team translates and validates all types of COAs, ensuring compliance with regulatory standards and providing translations for regulated content.
Certified translation
Our team of expert linguists provides meticulous, certified translations, ensuring your documents meet the highest standards of accuracy and compliance. We offer professional language translation for regulatory affairs to ensure every detail is correct.
On-site staffing
Need language assistance in a new market? Our on-site staffing solutions deliver high-quality language support quickly and efficiently. We empower you to easily navigate international business, providing expert translators on-site when and where you need them.
