Sesen – The Leader in Professional Regulatory Labeling Translation
Accurate regulatory labeling translations are essential in the life sciences industry, ensuring that pharmaceutical, biotechnology, and medical device products comply with global regulatory requirements while safeguarding patient safety. Misinterpretations or errors in labeling can lead to compliance failures, product recalls, and safety risks, making precision and consistency non-negotiable.
At Sesen, we specialize in accurate, compliant, and market-ready labeling translations in 150 languages. Our expert linguists, advanced translation technologies, and rigorous quality assurance process ensure that every translated label meets the strict standards of FDA, EMA, MDR, PMDA, CFDA, and other global regulatory bodies. Whether for prescription drug labels, patient information leaflets (PILs), or medical device instructions (IFUs), we help life sciences companies confidently navigate international markets with flawless, regulatory-compliant translations.
Why Regulatory Labeling Translation is Critical in Life Sciences
Accurate regulatory labeling translation plays a vital role in the life sciences industry, ensuring that pharmaceutical, biotechnology, and medical device products are safe, effective, and compliant across global markets. Errors or inconsistencies in translated labeling can lead to serious consequences, including regulatory rejection, product recalls, and patient harm.
Ensuring Patient Safety and Proper Product Usage
Clear, precise labeling prevents misinterpretation of dosage instructions, contraindications, warnings, and side effects, reducing the risk of medication errors and adverse events.
Meeting International Regulatory Requirements
Global regulatory agencies such as the FDA (U.S.), EMA (Europe), MHRA (UK), CFDA (China), and PMDA (Japan) enforce strict labeling standards. Compliance with these requirements is essential to obtain market approval and maintain regulatory adherence.
Avoiding Costly Recalls and Regulatory Penalties
Translation errors in labeling can result in delays, fines, or forced product withdrawals, causing financial losses and reputational damage. Ensuring accuracy from the outset mitigates compliance risks.
Supporting Global Market Entry and Product Commercialization
As life sciences companies expand internationally, localized, compliant labeling is critical for a smooth regulatory approval process and successful product launch in diverse linguistic and cultural markets.
Sesen provides high-quality, regulatory-compliant labeling translations that help life sciences companies protect patients, maintain compliance, and achieve seamless global market access with confidence.
Our Expertise in Regulatory Labeling Translation
Sesen delivers precise, compliant, and high-quality labeling translations tailored for the pharmaceutical, biotechnology, and medical device industries. Our expertise ensures that every translation meets regulatory standards, maintains linguistic accuracy, and adheres to industry best practices.
Specialized Life Sciences Linguists
Our translations are performed by native-speaking experts with deep domain knowledge in pharmaceuticals, medical devices, and biotechnology. Each linguist undergoes rigorous vetting to ensure scientific and regulatory proficiency, delivering translations that are both technically accurate and culturally appropriate.
Regulatory Compliance Specialists
We ensure that all translations align with region-specific regulatory requirements, including FDA (U.S.), EMA (Europe), MHRA (UK), CFDA (China), PMDA (Japan), and Health Canada guidelines. Our specialists stay updated on evolving regulations to guarantee that labeling translations remain fully compliant and market-ready.
Terminology Consistency
Maintaining precise terminology is critical in regulatory labeling. We use validated terminology databases such as MedDRA, EDQM, USP, and client-specific glossaries to ensure consistency, accuracy, and compliance across all translated materials.
Quality Assurance & Validation
Sesen follows a comprehensive quality control process, including the Translation, Editing, and Proofreading (TEP) methodology to ensure accuracy and regulatory alignment. When required, we implement back translation and reconciliation to verify critical safety and regulatory content, ensuring compliance with international standards.
Technology-Driven Accuracy
We leverage AI-assisted translation tools, translation memories, and terminology management systems to enhance efficiency, consistency, and accuracy while reducing turnaround times. Our technology-driven approach ensures that translated content remains precise, regulatory-compliant, and optimized for global distribution.
Types of Regulatory Labeling Documents We Translate
Sesen provides high-quality translations for a wide range of regulatory labeling documents. Our expertise covers critical labeling materials required for pharmaceuticals, medical devices, and biotechnology products, consistent with international regulatory standards.
Packaging and Labeling Components
Includes cartons, blister packs, leaflets, and booklets containing essential product and regulatory information. These materials must be translated accurately to ensure proper usage, patient safety, and compliance with market-specific labeling requirements.
Patient Information Leaflets (PILs)
Informational documents provided with medicines to help patients understand dosage, side effects, contraindications, and proper use. Accurate translation is essential to ensure patient comprehension and adherence.
Instructions for Use (IFUs)
Mandatory for medical devices, IFUs provide detailed usage instructions, precautions, and safety guidelines. Translations must comply with medical device regulations such as FDA requirements in the U.S. and MDR standards in the European Union.
Summary of Product Characteristics (SmPCs)
Essential regulatory documents used in the European Union, SmPCs provide healthcare professionals with detailed information on a medicine’s properties, indications, and usage. Precision in translation is critical for regulatory approval and patient safety.
Drug Facts Labels and Over-the-Counter (OTC) Packaging
Required for non-prescription medications, these labels contain dosage guidelines, active ingredients, warnings, and usage instructions. Translations must ensure that regulatory terminology is accurately conveyed for consumer safety and compliance.
Medical Device Labels and UDI Requirements
Labels for medical devices must include regulatory symbols, warnings, and essential product details. Unique Device Identification (UDI) regulations, mandated by FDA, MDR, and other agencies, require precise translations to meet traceability and compliance standards.
Safety Data Sheets (SDS) and Hazard Labels
Required for chemical and pharmaceutical products, SDS documents outline safety precautions, handling procedures, and hazard classifications. Compliance with international regulations, such as OSHA, GHS, and REACH, demands accurate and standardized translations.
Clinical Trial Labels
Used in investigational drug studies, these labels provide critical information for researchers and trial participants, including dosage, storage conditions, and blinded study identifiers. Translations must meet Good Clinical Practice (GCP) guidelines to ensure regulatory adherence and patient safety.
Our Translation Process
Sesen follows a structured, quality-driven approach in line with ISO 17100 and ISO 13485, ensuring labeling translations meet the highest standards of accuracy, compliance, and clarity. Our process ensures regulatory compliance while delivering high-quality labeling translations that support seamless market entry and approval.
Requirement Analysis
We begin by analyzing the product type, target markets, and applicable regulatory requirements. This ensures that translations meet the specific guidelines set by authorities such as the FDA, EMA, MDR, PMDA, and CFDA. Any client-specific terminology, formatting preferences, or compliance mandates are incorporated at this stage.
Translation & Terminology Alignment
Experienced linguists with subject matter expertise in pharmaceuticals, biotechnology, or medical devices are assigned to the project. We leverage translation memory tools, validated terminology databases, and client glossaries to maintain consistency and accuracy across all labeling materials.
Regulatory Review & Compliance Check
Translated content is reviewed to ensure compliance with regulatory formatting and content requirements. This step verifies that all essential product information, warnings, and instructions are correctly translated and structured to meet country-specific labeling standards.
Linguistic & Functional QA
A thorough quality assurance process is conducted, including in-country review by native-speaking experts. When necessary, back translation and reconciliation are performed to validate the accuracy of critical safety and regulatory information. Functional checks ensure that the translated content maintains its intended meaning across different languages and cultural contexts.
Final Verification & Delivery
The final translated materials undergo formatting, layout validation, and print-readiness checks. Our team ensures that all labeling components, including packaging inserts, instructions for use, and regulatory documents, are properly formatted and aligned with submission requirements before delivery.
Technology & Tools for Enhanced Accuracy
Sesen leverages advanced technology and industry-leading tools to ensure the highest level of accuracy, consistency, and compliance in regulatory labeling translations. Our technology-driven approach enhances efficiency while maintaining strict quality and security standards.
Machine Translation Post-Editing (MTPE) with Expert Oversight
When appropriate, we use MTPE to improve efficiency while ensuring every translation undergoes thorough human review and refinement. Our linguists validate accuracy, ensure regulatory compliance, and adapt the content for the target audience.
Translation Memory and Terminology Databases
Our translation memory tools store previously approved translations, ensuring consistency across all labeling materials while reducing costs and turnaround times. We also maintain industry-specific terminology databases, including MedDRA, EDQM, and USP, to ensure regulatory alignment.
ISO-Certified Quality Management System
Our processes adhere to ISO 17100 and ISO 13485 standards, ensuring a structured, quality-controlled workflow. This guarantees that all translations meet regulatory and industry best practices while maintaining linguistic and technical accuracy.
Secure Platform for Handling Confidential Regulatory Data
We prioritize data security with an encrypted, access-controlled platform designed to protect sensitive regulatory content. Our secure infrastructure ensures compliance with industry regulations, including GDPR and HIPAA, for confidential handling of life sciences materials.
Why Choose Sesen for Regulatory Labeling Translations?
Sesen is a trusted partner for life sciences companies seeking precise, compliant, and market-ready regulatory labeling translations. Our expertise, quality-driven processes, and commitment to regulatory compliance ensure that pharmaceutical, biotechnology, and medical device manufacturers can confidently navigate global markets.
Industry Expertise in Pharmaceuticals, Biotechnology, and Medical Devices
Our team specializes in life sciences translations, ensuring that every labeling document meets the highest linguistic, scientific, and regulatory standards. We understand the complexities of industry-specific terminology and compliance requirements across different regions.
ISO 17100 & ISO 9001:2015 Certified Translation Services
Our certified quality management system guarantees that all translations undergo rigorous validation, adhering to internationally recognized best practices. These certifications reflect our commitment to delivering accurate, reliable, and compliant translations.
Dedicated Regulatory Affairs Translation Team
We have a specialized team of translators and subject matter experts with deep knowledge of regulatory requirements, ensuring that all labeling translations meet the standards set by agencies such as the FDA, EMA, MHRA, PMDA, and CFDA.
Dedicated Regulatory Affairs Translation Team
We have a specialized team of translators and subject matter experts with deep knowledge of regulatory requirements, ensuring that all labeling translations meet the standards set by agencies such as the FDA, EMA, MHRA, PMDA, and CFDA.
Proven Experience Working with Leading Life Sciences Companies
Sesen has a strong track record of delivering high-quality regulatory labeling translations for some of the world’s top pharmaceutical, medical device, and biotech companies. Our experience allows us to anticipate challenges and provide seamless solutions.
Scalable Solutions for High-Volume, Time-Sensitive Projects
We offer flexible, scalable translation workflows to accommodate urgent regulatory submissions, product launches, and updates. Our efficient project management ensures that even complex, large-scale labeling translation projects are delivered on time without compromising quality.
