Unlock Global Markets with Expert Life Sciences Translation Services
Successful market entry in the life sciences sector requires more than innovative products—it demands accurate, compliant, and culturally adapted communication across global regions. Language barriers can delay regulatory approvals, reduce patient engagement, and limit access to international markets.
Sesen provides specialized translation and localization services tailored to life sciences companies—including pharmaceutical, biotech, medical device, and CRO organizations—to support every stage of global market entry. Our ISO-certified workflows and subject-matter expertise ensure that regulatory submissions, clinical content, and patient-facing materials are translated with precision and aligned with regional requirements.
From multilingual regulatory submissions and labeling to patient engagement materials and digital health content, Sesen helps life sciences companies overcome language obstacles and launch confidently in new markets.
Overcoming Language, Regulatory, and Cultural Barriers
Entering global markets in the life sciences sector involves navigating a complex matrix of regional regulations, linguistic diversity, and cultural nuances. Each target market—whether regulated by the FDA, EMA, NMPA, PMDA, MHRA, ANVISA, or other authorities—imposes specific requirements for language use, documentation formats, and patient-facing materials.
Compliance with multilingual labeling and packaging standards is mandatory, often requiring precise translations reviewed and approved by local regulators. Beyond technical accuracy, cultural adaptation is critical to ensure patient instructions, consent forms, and educational materials are accessible, understandable, and culturally relevant across diverse populations.
Language and literacy barriers can also significantly impact clinical trial recruitment and patient adherence. Low health literacy or poorly localized content may lead to misinterpretation, regulatory setbacks, or compromised patient safety. Sesen addresses these challenges with expert linguistic solutions designed to meet both regulatory and human factors across all global markets.
End-to-End Language Services for Life Sciences Globalization
Sesen delivers integrated translation and localization solutions that support every stage of global market entry for life sciences organizations. Our services are engineered to meet regulatory, clinical, and commercial demands across multilingual environments.
Regulatory and Compliance Translations
We provide precise, ISO 17100-certified translations to support regulatory submissions and documentation required by global health authorities, including the FDA, EMA, MHRA, NMPA, PMDA, and ANVISA. Our linguists have subject-matter expertise to ensure terminology accuracy, consistency, and compliance across clinical trial protocols, safety reports, quality documentation, and labeling.
Patient-Focused Translations
Effective patient engagement depends on content that is not only accurate but also accessible. We translate and culturally adapt informed consent forms (ICFs), patient diaries, drug information leaflets, instructions for use (IFUs), and packaging labels to promote comprehension, adherence, and safety. All content is written in clear, plain language to address health literacy challenges across diverse populations.
Multilingual Digital Content
Our digital localization services enable life sciences companies to deliver consistent user experiences across markets. We translate and localize websites, mobile applications, and patient portals to meet regional requirements and user expectations. Multimedia capabilities include professional voice-over, subtitle creation, and video localization for patient education and training content.
Sesen’s comprehensive language solutions accelerate international launch readiness, ensure compliance, and enhance patient communication in any market.
Technology-Driven Human Translation Solutions
At Sesen, we provide professional human translation powered by the latest language technologies for all critical life sciences content, including regulatory submissions, clinical documentation, and patient-facing materials. Our linguists are subject-matter experts who ensure accuracy, clarity, and compliance across languages and markets.
For non-critical or high-volume content, we offer Machine Translation Post-Editing (MTPE) as a cost-effective alternative. In this workflow, raw machine output is carefully reviewed and edited by experienced linguists to meet quality standards while improving turnaround times and scalability.
To support consistency, we leverage AI-powered terminology management and translation memory systems, enabling precise use of technical terms and more efficient processing across multilingual projects. This hybrid approach allows our clients to balance speed, quality, and budget—without compromising regulatory compliance or patient safety.
Adapting to Local Regulatory, Cultural, and Linguistic Expectations
Each global market presents unique linguistic, regulatory, and cultural challenges that must be addressed to ensure successful product launch and sustained patient engagement. Sesen provides tailored translation solutions that align with regional requirements and healthcare communication standards.
Europe
The European Union mandates multilingual compliance under the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR), often requiring up to 24 official languages depending on the market. Sesen delivers accurate, compliant translations for labeling, IFUs, and patient materials—ensuring consistency across member states while meeting tight regulatory timelines.
China & Japan
Both countries enforce strict language requirements for patient-facing content and regulatory submissions. In China, the NMPA mandates Chinese-language documentation for clinical trials and product registration, while Japan’s PMDA requires culturally sensitive translations that conform to domestic medical terminology standards. Sesen’s native linguists and in-country reviewers ensure full regulatory alignment and cultural appropriateness.
Latin America
Spanish and Portuguese are spoken across the region, but significant dialectal and terminology variations exist between countries such as Mexico, Argentina, Brazil, and Colombia. Sesen localizes content for each target country, ensuring that medical terminology, tone, and phrasing reflect local usage, regulatory norms, and cultural expectations.
Middle East & Africa
Markets in this region present distinct challenges, including right-to-left (RTL) script formatting for Arabic and low health literacy in some populations. Sesen provides linguistically accurate and culturally appropriate translations, while also applying plain language principles and visual formatting best practices to improve accessibility and comprehension across diverse patient groups.
Through regional expertise and a global linguistic network, Sesen helps life sciences companies navigate market-specific complexities with confidence and compliance.
Ensuring Accuracy, Consistency, and Compliance in Translations
Sesen is a trusted partner to leading pharmaceutical, biotech, medical device, and CRO organizations seeking to enter and operate in global markets. Our specialized language solutions are built on deep industry expertise, regulatory insight, and a commitment to precision.
Certified Translation Workflows
Our processes are fully compliant with ISO 17100 (translation services) and ISO 13485 (medical device quality management systems), ensuring that all translations meet international standards for accuracy, traceability, and quality control. Each project follows a structured workflow with dedicated linguists, independent reviewers, and final quality assurance checks.
Subject-Matter Expertise
We assign only qualified linguists with subject-matter expertise in medical, regulatory, and technical domains relevant to the life sciences sector. These professionals are well-versed in complex terminology, therapeutic areas, and global regulatory language requirements, enabling us to produce translations that are both precise and submission-ready.
Technology-Enabled Consistency
To ensure terminological consistency across large-scale, multilingual projects, we utilize AI-driven translation memory (TM) systems and terminology management tools. These technologies enable reuse of previously approved content, reduce human error, and accelerate project turnaround while maintaining linguistic precision.
The Sesen Advantage in Life Sciences Translations
Sesen is a trusted partner to leading pharmaceutical, biotech, medical device, and CRO organizations seeking to enter and operate in global markets. Our specialized language solutions are built on deep industry expertise, regulatory insight, and a commitment to precision.
Proven Industry Experience
With a strong track record supporting global regulatory submissions, clinical trials, and product launches, Sesen understands the unique language and compliance demands of life sciences companies across highly regulated markets.
Dedicated Project Management
Each engagement is led by a dedicated project manager who oversees timelines, resource coordination, and quality assurance. Clients receive structured progress updates and full transparency from initiation through final delivery.
Tailored Language Solutions
We provide customized translation workflows that align with your global market entry strategy—whether you’re launching in a single region or across multiple jurisdictions. From regulatory labeling to patient engagement materials, our solutions are scaled and configured to meet the linguistic, cultural, and operational requirements of your target markets.
With Sesen, you gain a partner equipped to manage complexity, ensure compliance, and accelerate your global expansion.
Real-World Impact of Sesen’s Global Market Entry Services
Sesen’s translation solutions have enabled life sciences organizations to navigate regulatory, linguistic, and cultural complexities in diverse markets. The following examples highlight our ability to drive measurable outcomes through specialized language support.
Case Study 1: Expanding Clinical Trial Participation Through Localized Patient Materials
A global pharmaceutical sponsor partnered with Sesen to improve enrollment in Phase III trials across Latin America and Eastern Europe. We delivered culturally adapted translations of informed consent forms, patient diaries, and recruitment materials in over 15 languages. The result: accelerated recruitment timelines and improved patient comprehension, contributing to higher retention rates and cleaner data.
Case Study 2: Ensuring Compliance with EMA and FDA Through Multilingual Documentation
A biotech firm preparing simultaneous regulatory submissions for the U.S. and EU required precise, compliant translations of clinical protocols, safety reports, and labeling content. Sesen implemented a dual-region workflow with regulatory-focused linguists and medical reviewers. The company successfully met submission deadlines and received positive regulatory feedback on the quality and clarity of its multilingual documentation.
Case Study 3: Launching a Medical Device in Asia and the Middle East
A medical device manufacturer needed localized labeling, IFUs, and digital content to launch its product in Japan, Saudi Arabia, and the UAE. Sesen provided translations in Japanese and Arabic, including right-to-left layout support and country-specific terminology adaptation. The client achieved full regulatory clearance and market launch within targeted timelines, while maintaining brand consistency across regions.
Get Started with Sesen’s Global Market Entry Services
Ready to navigate regulatory complexity, accelerate time to market, and engage global patients with confidence? Sesen’s life sciences translation experts are here to support your market entry strategy with precision and speed.
Contact us today to discuss your global expansion goals and learn how our tailored language solutions can drive success.
