Language Scientific provides regulatory translation services for life sciences and other regulated industries. Our scientific and technical specialists handle complex documentation with close attention to terminology, context, and accuracy across languages.
For FDA, EMA, and other global regulatory processes, that expertise helps reduce the risk of translation-related questions, rework, and delays.
Regulatory requirements vary by industry, country, and type of documentation. The following are examples of regulations, standards, and related translation services that support organizations working across international markets.
Language Scientific has provided regulatory translation services since 1999, working with industry specialists who understand the technical content behind the documents they translate. That depth of knowledge matters when regulatory requirements and terminology differ across countries and regions.
To support this work, we draw on our Advanced Scientific Knowledge network (ASKnetwork™), which includes more than 5,000 translators, interpreters, and localization experts with advanced scientific or technical degrees and professional experience in their fields.
That expertise is reinforced by a structured quality review process. Language Scientific’s Quality Management System is certified to ISO 9001:2015 and ISO 17100:2015, and our translation process includes three sets of eyes: a translator, an editor, and a proofreader. These checks help maintain accuracy and consistency in sensitive regulatory documentation.
To give you even more peace of mind, we offer a Certificate of Translation Accuracy with every translation project.
Regulatory documents often contain terminology whose meaning depends on scientific context, the intended audience, or the requirements of a particular market. We combine subject-matter expertise with fit-for-purpose technology to address these challenges throughout the translation process.
Review focus | How we address it |
|---|---|
Scientific and technical meaning | Our medical, scientific, and technical specialists assess terminology in context, particularly where a literal translation could change the intended meaning. |
Terminology consistency | Translation technology helps identify inconsistent terminology across related documents, while our specialists determine whether differences are appropriate or need correction. |
AI-assisted translation | When AI is appropriate for a project, our specialists review its output for errors in terminology, context, and meaning rather than relying on automated results alone. |
LS Certified quality assurance | Our LS Certified methodology provides expert review and certification for manual, AI-assisted, and AI-generated translations, with documented quality assurance for sensitive regulatory materials. |
Regulatory translation may involve product labeling, instructions for use, technical files, safety data sheets, clinical documentation, and submission materials. Which documents require translation depends on the industry, intended market, and applicable regulatory requirements.
No. Certification requirements vary by regulatory authority, document type, and submission procedure. Some submissions require a certificate or declaration of translation accuracy; others have different documentation requirements. Confirm what's required before translation begins.
LS Certified is our methodology for expert review and certification of manual, AI-assisted, and AI-generated translations. A Certificate of Translation Accuracy documents the accuracy of the completed translation. Additional requirements depend on the receiving regulatory authority.
Not necessarily. Even when countries share a language, regulatory terminology, labeling conventions, and documentation requirements may differ. Before reusing a translation, check it against the requirements of each destination market and the document's intended use.
Check technical terminology, warnings, instructions, measurements, and consistency with source documentation. For medical and pharmaceutical products, small wording differences can change how users understand safety information or follow instructions, making careful review essential.
Safety data sheets contain specialized chemical terminology, hazard classifications, precautionary statements, and technical details. Requirements can differ between markets, so translations must account for the terminology and regulatory conventions applicable to the intended destination.
Source revisions may require updates to translated versions and another review, particularly when warnings, specifications, or defined terminology change. Clear version control helps identify affected passages and prevents inconsistencies across related regulatory documents.
Yes. Regulatory materials often contain tables, numbered instructions, warnings, and structured fields that must remain clear after translation. Confirm formatting requirements early, especially when content must fit an existing label, form, or submission template.
Turnaround depends on document length, language pair, technical complexity, and the level of review required. Providing current source files, reference terminology, and a clear deadline helps our team assess a realistic project schedule.
Pricing depends on document volume, language pair, technical complexity, formatting, and required specialist review. Share the content's intended use and delivery requirements so our team can recommend a suitable workflow and define the project scope.
Regulatory translation projects depend on the documents involved, where they’ll be used, and the deadlines you’re working toward. Our team will review your requirements, identify the right subject-matter expertise, and determine the quality checks needed for your materials.
Share your project details with us, and we’ll recommend a translation workflow that supports your documentation and timeline.
