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Expert Labeling Translation for Regulatory Compliance Across Global Markets

Sesen delivers precise and compliant labeling translation services for the life sciences industry, supporting pharmaceutical, biotechnology, and medical device companies across all phases of development and commercialization. Our regulatory label translation solutions cover drug packaging, device labeling, IFUs, and diagnostics content, ensuring linguistic accuracy and consistency in over 150 languages. With deep knowledge of global regulatory frameworks such as FDA, EMA, EU MDR, IVDR, and PMDA, we help clients produce submission-ready packaging translations that meet the strict requirements of health authorities worldwide. Our integrated workflows combine multilingual labeling solutions, native subject-matter linguists, and in-context QA to minimize risk and accelerate global product approvals.

Why Accurate Labeling Translation Matters

In the life sciences industry, label translation accuracy is essential to protecting patient safety, minimizing regulatory risk, and ensuring global market access. Labels contain critical product information, including dosage instructions, contraindications, storage conditions, and device operation guidelines, which must be clearly understood in every target language to avoid misinterpretation and misuse.

Errors in drug and medical device labeling can result in regulatory rejection, delayed market entry, product recalls, or liability exposure. Health authorities such as the FDA, EMA, and PMDA enforce strict requirements for labeling content, terminology consistency, and language quality. Even minor mistranslations can compromise regulatory acceptance and pose serious risks to public health.

Accurate, compliant, and submission-ready labeling translations help life sciences companies secure marketing authorization, reduce time-to-market, and maintain trust with global regulatory agencies. At Sesen, we apply rigorous linguistic QA and native subject-matter expertise to every labeling project to ensure both technical precision and real-world usability.

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Types of Labels We Translate

We translate a wide range of life sciences labels, from pharmaceutical inserts and device packaging to complex diagnostic IFUs, in over 150 languages. Our labeling solutions support regulatory compliance, patient safety, and market approval across all global regions.

Multilingual translations of prescription and over-the-counter drug labels, including product packaging, inserts, and medication guides that align with FDA, EMA, and global pharmacovigilance standards.

Translation of device packaging, software interface labels, and operating instructions to meet EU MDR, IVDR, and country-specific labeling requirements for Class I, II, and III devices.

Specialized translation of Instructions for Use and user manuals for medical devices, diagnostics, and combination products, ensuring clarity, accuracy, and layout consistency in all languages.

Post-layout linguistic review and in-context QA to validate label accuracy, formatting integrity, and regulatory compliance before submission or print.

Regulatory Standards We Support

Sesen’s labeling translation services are designed to meet the complex requirements of global health authorities. Our team ensures that translated labels align with regional regulations, terminology standards, and formatting rules to support successful product registration and market access.

Translation of labeling and packaging content for centralized and decentralized procedures in compliance with EMA templates and QRD requirements.

U.S. label translation services aligned with FDA labeling guidance for prescription drugs, OTC products, and Class I–III medical devices, including medication guides and instructions for use.

Multilingual support for IVD device labels and IFUs to meet stringent IVDR language requirements for EU market approval.

Translation of device labeling and instructions for Class I–III products in compliance with EU MDR language mandates and risk classification rules.

Regulatory label translation tailored to national authority requirements, including country-specific terminology, structure, and review expectations.

Support for Unique Device Identification (UDI) translation, barcode formatting, and region-specific label configuration to ensure traceability and compliance across jurisdictions.

Sesen combines language expertise with regulatory insight to deliver labeling content that is both linguistically accurate and globally compliant.

Our Translation & QA Process

Sesen applies a structured, end-to-end process to deliver labeling translations that are not only linguistically accurate but also fully compliant with international regulatory standards. Each stage is designed to minimize risk, enhance consistency, and streamline approval across global markets.

We implement standardized terminology management using client-approved glossaries, industry style guides, and validated medical and regulatory terminology. This ensures consistent use of critical terms across product families, regions, and regulatory submissions while aligning with health authority expectations.

Our labeling translations are performed exclusively by professional native linguists with subject-matter expertise in pharmaceuticals, medical devices, and diagnostics. These translators are trained in regulatory documentation and familiar with the labeling requirements of agencies such as the FDA, EMA, and PMDA.

We offer full support for desktop publishing and multilingual label formatting, including font and layout compliance, insert and carton design, and language-specific requirements such as right-to-left formatting and character expansion. Our team works directly with your label templates to ensure accurate content placement and visual alignment.

Before delivery, every label undergoes in-context linguistic review to verify accuracy within the actual layout. Our QA experts check for truncation, formatting issues, misplaced line breaks, and alignment with regulatory submission requirements. This final validation step ensures the label is ready for print or electronic submission.

AI-Supported Human Translation for Regulatory Labeling

Sesen combines the precision of human expertise with the efficiency of AI-powered tools to deliver high-quality, regulator-ready labeling translations. Our hybrid workflows are designed to accelerate delivery without compromising compliance, linguistic accuracy, or submission readiness.

We use proprietary AI tools such as SesenGPT to assist with glossary extraction, terminology alignment, and pre-delivery quality assurance. These technologies support greater consistency across product lines and reduce manual effort, especially for large-scale multilingual projects.

Where appropriate, Machine Translation Post-Editing (MTPE) is available for select content types. MTPE is used only when it meets regulatory and quality thresholds, and is always performed by trained linguists with domain-specific knowledge.

Critically, all regulatory content, including drug labels, medical device IFUs, and diagnostic packaging, is subject to full human review by native-speaking experts with experience in global health authority requirements. This ensures that every label delivered by Sesen meets the highest standards of accuracy, compliance, and patient safety.

Related Services

Sesen offers a full suite of complementary services that enhance the accuracy, formatting, and regulatory readiness of your labeling content. Our integrated solutions help streamline workflows and ensure consistency across every stage of your global product launch.

Multilingual translation of regulatory documents including eCTD modules, clinical trial applications (CTAs), and global marketing authorization dossiers. Our team ensures terminology alignment between labels and submission content for greater consistency and faster approvals.

Full DTP support for product labels, leaflets, cartons, and IFUs. We manage layout design, formatting, and font compliance across all languages to deliver press-ready or electronically formatted label files.

Native linguists conduct post-layout reviews of translated labels to validate content accuracy, layout integrity, and visual consistency before print or regulatory submission. This service is critical for avoiding costly errors and regulatory delays.

Industries & Use Cases

Sesen supports a wide range of life sciences sectors with tailored labeling translation solutions that meet the specific regulatory and operational needs of each product category. Our industry expertise ensures that all translated labels are accurate, compliant, and ready for global distribution.

Translation of prescription and over-the-counter drug labels, medication guides, and packaging inserts in compliance with FDA, EMA, and other regional regulatory bodies.

Labeling support for cell and gene therapies, biologics, and RNA-based products, with careful attention to evolving terminology and compliance frameworks.

Multilingual labeling for diagnostic and therapeutic devices across risk classes, aligned with EU MDR, FDA, and other regulatory authority requirements.

Translation of IFUs, packaging, and device labeling for IVD products under IVDR and country-specific regulations to support accurate use and safe patient outcomes.

Support for IMP labeling, secondary packaging, and investigator materials to ensure clarity, compliance, and alignment with clinical protocols in multilingual study environments.

Case Studies & Client Success

Sesen has successfully delivered high-impact labeling translation solutions for leading global life sciences companies. Our case studies demonstrate how we help clients navigate complex regulatory environments, manage multilingual labeling across markets, and accelerate time to approval with precision and efficiency.

A global medical device manufacturer partnered with Sesen to translate IFUs and packaging for viral infection diagnostics into 15 languages for simultaneous deployment in EU, APAC, and LATAM regions. Our workflow included terminology harmonization, multilingual DTP, and in-context QA to support IVDR compliance.

For a leading CRO managing a global vaccine submission, Sesen provided end-to-end regulatory translation and label alignment across 25 languages. The project required integration of labeling updates within eCTD modules and adherence to regional authority standards including WHO, EMA, and national health agencies.

FAQs

Labeling translation in life sciences involves the accurate conversion of product labeling content, such as packaging, inserts, IFUs, and device instructions, into multiple target languages. This process requires domain-specific knowledge, regulatory expertise, and consistency across therapeutic areas to ensure global compliance and safe product use.

Sesen follows strict regulatory protocols to align translated labels with the specific requirements of authorities like the FDA, EMA, and national agencies enforcing EU MDR and IVDR. We apply validated glossaries, approved style guides, and in-context QA checks to ensure that every label is linguistically correct, visually accurate, and submission-ready.

Sesen supports labeling translations in over 150 languages, covering all major global markets including North America, Europe, LATAM, APAC, and the Middle East. Our global linguist network includes native-speaking experts with specialized experience in life sciences and regulatory documentation.

Yes. Our multilingual desktop publishing team works with your source design files to format translated labels for packaging, inserts, and IFUs. We maintain layout integrity, font compliance, and proper text flow for all languages, including right-to-left and double-byte character scripts.

Need Accurate, Regulator-Ready Label Translations?

Ensure your product labels meet global regulatory standards with Sesen’s expert labeling translation services. We deliver compliant, high-quality multilingual packaging and labeling solutions across 150+ languages for pharmaceuticals, medical devices, diagnostics, and clinical trials.

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