Labeling Translation Services for Global Regulatory Compliance
Accurate, compliant translations for chemical, pharmaceutical, medical device, and consumer product labels in 100+ languages.
Stepes provides specialized labeling translation services to help companies meet complex global regulatory requirements. Our expert linguists deliver precise, compliant translations that ensure accuracy, consistency, and safety across product labels. From GHS, CLP, and REACH to FDA and EU MDR, we support chemical, pharmaceutical, medical device, and consumer product labeling in over 100 languages.
What Are Labeling Translation Services?
Labeling translation services involve the precise adaptation of product labels into multiple languages to meet regulatory, safety, and consumer communication requirements across international markets. Unlike standard translation, labeling requires deep subject matter expertise and strict adherence to global and local regulations to ensure compliance, consistency, and clarity.
For hazardous chemicals, labeling translation covers Globally Harmonized System (GHS), EU CLP, and REACH regulations, including hazard statements, precautionary phrases, and safety pictograms. In pharmaceuticals, it includes drug packaging, dosage instructions, patient inserts, and Instructions for Use (IFUs) that must comply with FDA, EMA, and other regulatory agency guidelines. Medical device labeling covers multilingual UDI identifiers, package inserts, and IFUs under EU MDR and ISO 13485 standards. For consumer products such as cosmetics, food, and household goods, labeling translations address ingredient declarations, allergen warnings, and country-specific compliance requirements.
Stepes provides professional safety data sheet translation solutions that combine subject matter expertise, industry-specific glossaries, and ISO-certified processes. Our certified translations help chemical, pharmaceutical, and industrial companies meet international safety regulations while ensuring employees and customers worldwide can access accurate hazard communication in their native language.
Why Labeling Translation Matters
Accurate labeling translation is essential for companies operating in highly regulated industries. Product labels serve as a critical communication tool for safety, compliance, and consumer trust, making professional translation a regulatory and business requirement.
Regulatory Compliance: Product labels must meet strict international standards such as OSHA GHS, EU CLP, REACH, FDA, EMA, MDR, and ISO 13485. Non-compliant translations can result in regulatory penalties, product recalls, or delays in market approval.
Consistency: Labeling content must remain consistent with safety data sheets (SDS), packaging inserts, and other technical documentation. Discrepancies create compliance risks and can compromise the integrity of regulatory submissions.
Product Safety: Labels communicate essential hazard information, usage instructions, and warnings. Accurate translations protect workers, healthcare professionals, and consumers from potential harm caused by misinterpretation.
Market Access: Multilingual labeling is often a prerequisite for product distribution in global markets. Correctly localized labels ensure products can be sold across different regions without regulatory or consumer acceptance issues.
Brand Integrity: High-quality labeling translations demonstrate professionalism and commitment to safety. Consistently accurate labeling builds customer confidence and strengthens brand reputation worldwide.
Industries We Support
Stepes delivers professional labeling translation services across a wide range of regulated and consumer-driven industries. Each sector has unique compliance and safety requirements, and our specialized linguists ensure that every label is translated with precision, consistency, and regulatory accuracy.
We translate GHS-compliant hazard labels, workplace safety instructions, and packaging content in line with CLP and REACH regulations. Our translations cover hazard statements, precautionary phrases, and safety pictograms to ensure compliance and worker protection.
Our labeling translations support global drug development and commercialization, including drug packaging, dosage instructions, patient inserts, and IFUs. We align translations with FDA, EMA, and ICH requirements to maintain compliance and ensure patient safety.
Stepes translates IFUs, UDIs, and product labeling in compliance with EU MDR, FDA regulations, and ISO 13485 standards. We provide in-context review to ensure multilingual labeling fits within packaging formats and meets regulatory expectations.
We support international product launches by translating ingredient lists, INCI nomenclature, allergen declarations, and packaging content. Our team adapts cosmetic and consumer product labeling to meet local regulations and cultural expectations.
Our translations cover nutrition facts, allergen information, and labeling formats required by regional authorities such as FDA, EFSA, and other food safety agencies. We ensure accuracy and compliance with country-specific regulations to facilitate international distribution.
Global Regulatory Standards We Support
Accurate labeling translation requires strict adherence to international regulations and industry standards. Stepes supports a wide range of global compliance frameworks to ensure product labels are consistent, legally valid, and ready for distribution in target markets.
We translate chemical hazard labels in compliance with the Globally Harmonized System, covering hazard pictograms, signal words, hazard statements, and precautionary phrases. Our expertise ensures multilingual labels meet OSHA and UN-recommended GHS requirements for workplace and consumer safety.
Stepes provides translations that align with EU CLP standards, including accurate hazard classifications and mandatory language requirements across all EU member states. We ensure labeling is fully compliant with EU chemical safety regulations for cross-border distribution.
Our labeling translations maintain consistency with registration dossiers and safety data sheets required under REACH. We help manufacturers and importers ensure accurate multilingual labeling that meets the European Chemicals Agency’s compliance framework.
Stepes translates pharmaceutical and biologic labeling to meet the requirements of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes drug packaging, prescribing information, patient inserts, and dosage instructions to support safe use and global market approval.
We deliver medical device labeling translations in line with the EU MDR, including Instructions for Use (IFUs), UDIs, and packaging content. Our processes are ISO 13485-certified, ensuring compliance with European regulatory expectations and device safety standards.
All Stepes translations follow ISO 17100 quality management for translation services. For life sciences and medical device labeling, we adhere to ISO 13485, which ensures translation workflows meet the highest standards for regulated industries.
Our Labeling Translation Process
Stepes follows a structured, ISO-certified process designed to deliver accurate, compliant, and market-ready labeling translations across all industries. Our workflows combine linguistic expertise with advanced technology to ensure regulatory accuracy, consistency, and efficiency.
We develop and maintain dedicated glossaries and terminology databases for hazard statements, pharmaceutical terminology, INCI ingredient names, and regulatory phrases. This ensures consistent use of approved terminology across all product labels and markets.
Our linguists cross-check labeling content against regulatory documents such as safety data sheets, registration dossiers, and product submissions. This prevents discrepancies that could compromise compliance or delay regulatory approval.
Stepes leverages advanced in-context translation tools that allow linguists to preview translations directly within label artwork. This ensures accurate text placement, correct line breaks, and compliance with space and formatting requirements.
Each translation undergoes bilingual QA review and automated validation against terminology databases. Formatting and regulatory compliance checks are performed to confirm that labels meet regional standards before delivery.
We handle complex packaging layouts using industry-standard tools such as Adobe InDesign and Illustrator. Our DTP specialists adapt multilingual content into regulatory-compliant templates while preserving design integrity across all target languages.
Technology Solutions for Labeling Translations
Stepes combines linguistic expertise with advanced translation technologies to deliver accurate, efficient, and compliant product labeling in over 100 languages. Our tools and workflows are designed to improve consistency, reduce costs, and accelerate time to market while meeting the strict requirements of regulated industries.
We leverage centralized TM systems and validated terminology databases to ensure consistent use of approved terms across safety data sheets, product labels, and packaging. This reduces errors and improves efficiency for large, multi-label projects.
Our linguists use in-context review tools that allow real-time visualization of translations directly within label artwork. This ensures that text fits correctly within space-constrained layouts and maintains compliance with formatting and design requirements.
Stepes applies automation to streamline workflows for projects involving multiple languages. Automated processes reduce manual steps, speed up turnaround times, and lower costs without compromising quality or regulatory compliance.
Where applicable, our workflows integrate with client regulatory information management systems. This helps synchronize labeling content with registration data, ensures alignment with regulatory submissions, and minimizes compliance risks.
Quality & Certifications
Stepes delivers labeling translation services backed by globally recognized quality standards and industry certifications. Our commitment to compliance and accuracy ensures that every project meets the highest benchmarks for regulatory and linguistic excellence.
All translation projects follow ISO 17100-certified processes, which set strict requirements for translator qualifications, review procedures, and quality assurance. This guarantees consistency, traceability, and accountability across every labeling project.
For medical device labeling, we operate under ISO 13485:2016-certified quality management systems. This certification ensures our translations meet the stringent requirements of the medical device industry, supporting compliance with EU MDR and FDA regulations.
Our workflows are specifically designed to align with European and U.S. regulatory expectations. Stepes translations support submissions and labeling requirements for pharmaceuticals, medical devices, and biologics, reducing the risk of regulatory delays or rejections.
We work exclusively with professional native translators who have subject matter expertise in chemistry, life sciences, and regulatory compliance. This specialized knowledge ensures accuracy in technical terminology, hazard communication, and multilingual packaging content.
By combining certified processes, regulatory alignment, and expert linguists, Stepes provides labeling translations that are precise, compliant, and trusted by leading global brands.
Case Studies / Client Use Cases
Stepes has extensive experience delivering multilingual labeling solutions for companies across regulated and consumer industries. Our work demonstrates how accurate, compliant translations help clients meet global regulatory requirements, reduce risk, and achieve faster market entry.
A leading global chemical producer relied on Stepes to translate GHS-compliant hazard labels into 25 languages for distribution across Europe, Asia, and Latin America. The project included hazard statements, precautionary phrases, and pictogram text, ensuring alignment with CLP and REACH regulations.
For a medical device manufacturer, we translated Instructions for Use (IFUs), Unique Device Identifiers (UDIs), and package labels into multiple EU languages. The translations were completed under ISO 13485-certified workflows, aligning with MDR standards and FDA expectations for device safety.
Stepes supported a top pharmaceutical company with multilingual drug packaging translations required for EMA submission. The work included dosage instructions, prescribing information, and patient inserts, ensuring full compliance with European regulatory requirements and supporting timely approval.
A global cosmetics brand partnered with Stepes to translate ingredient declarations, INCI names, and allergen information for packaging distributed across Asian and EU markets. Our multilingual DTP team adapted the content into packaging templates, ensuring regulatory compliance and consistent brand presentation worldwide.
By combining regulatory expertise with advanced translation technologies, Stepes helps companies in every sector achieve accurate, compliant, and market-ready labeling for international success.
Related Services
Labeling translation is closely connected to other regulatory and technical documentation workflows. Stepes provides a full suite of specialized translation services to ensure consistency, compliance, and efficiency across all product safety and regulatory communications.
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Accurate translation of Safety Data Sheets (SDS) in over 100 languages to meet global GHS, CLP, and REACH requirements. Our SDS translations are fully aligned with labeling content to ensure regulatory compliance and hazard communication accuracy.
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Specialized translation services for medical device labels, UDIs, and Instructions for Use (IFUs). Our ISO 13485-certified workflows ensure compliance with EU MDR, FDA, and international regulatory standards, enabling safe and compliant device distribution worldwide.
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Professional translations of Instructions for Use (IFUs) for medical devices and pharmaceuticals. Our ISO 13485-certified workflows guarantee accuracy, compliance, and readability for healthcare professionals and patients worldwide.
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Stepes helps companies manage multilingual compliance across chemical, pharmaceutical, and consumer product markets. Our integrated solutions cover SDS, labeling, IFUs, and packaging to reduce compliance risks and streamline international product launches.
Frequently Asked Questions About Labeling Translation
Labeling translation services involve the precise translation and localization of product labels into multiple languages to meet regulatory, safety, and consumer requirements. This includes chemical hazard labels, pharmaceutical packaging, medical device IFUs and UDIs, cosmetics, food, and consumer product labels.
Accurate translations ensure product labels meet global regulatory frameworks such as GHS, CLP, REACH, FDA, EMA, and EU MDR. Errors in labeling can result in regulatory fines, product recalls, or safety risks for consumers and workers.
Stepes provides professional labeling translation services in over 100 languages, covering all major global markets. Our network of native linguists ensures cultural and regulatory accuracy across each target language.
Yes. Stepes translations follow GHS and EU CLP requirements, including hazard statements, precautionary phrases, signal words, and pictograms. We ensure multilingual hazard labels are consistent, compliant, and ready for international distribution.
Absolutely. Stepes provides full multilingual desktop publishing (DTP) support using tools such as Adobe InDesign and Illustrator. We adapt translations to packaging layouts and regulatory-compliant templates to ensure accurate fit and professional presentation.
Ready to Streamline Your Global Labeling Compliance?
Stepes provides fast and reliable labeling translation services across chemicals, pharmaceuticals, medical devices, cosmetics, food, and consumer products. Our expert linguists and ISO-certified processes ensure every label meets international regulatory requirements while protecting safety and supporting global market access. Partner with Stepes for accurate, compliant, and multilingual labeling solutions that build trust and reduce compliance risks.
