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Life Sciences Software Localization

In the life sciences industry, software and app localization is more than just translation—it’s about ensuring regulatory compliance, enhancing user experience, and enabling global market access. From pharmaceutical platforms and medical device software to eClinical applications and patient-facing apps, accurate localization is essential for usability, safety, and compliance with regional health authorities.

  • Regulatory Compliance: Adapting software to meet FDA, EMA, CFDA, and PMDA regulations, ensuring approvals and avoiding costly compliance issues.
  • Precision & Patient Safety: Inaccurate translations in medical software can lead to misdiagnosis, treatment errors, or regulatory penalties.
  • Enhanced User Experience: Clinicians, researchers, and patients rely on intuitive, culturally adapted software interfaces that function seamlessly in multiple languages.
  • Global Market Expansion: Proper localization helps life sciences companies scale internationally, unlocking new revenue streams and improving user adoption.
  • Regulatory Complexity: Different markets impose stringent requirements on terminology, labeling, and software UI adaptations.
  • Technical Constraints: Adapting medical software UI, UX, and structured data fields while ensuring multilingual compatibility.
  • Real-Time Data Handling: eClinical and health apps must maintain data integrity across languages without affecting functionality.
  • Industry-Specific Terminology: Life sciences require precise, controlled vocabulary to avoid misinterpretation in clinical and patient-facing applications.

With specialized expertise in life sciences, Sesen delivers fully compliant, user-friendly, and market-ready software localization solutions tailored to the unique demands of the industry.

The Critical Role of Software Localization

In the highly regulated life sciences industry, software localization is essential to ensure compliance, accuracy, and patient safety in global markets. Whether it’s clinical trial management platforms, medical device interfaces, or patient engagement apps, precise localization is key to regulatory approval and seamless user adoption.

Life sciences software must meet strict regulatory standards across different regions, including FDA (U.S.), EMA (Europe), CFDA (China), and PMDA (Japan). Compliance involves accurate translation of user interfaces (UI), software documentation, and in-app instructions to align with legal and safety requirements, preventing delays in market entry and regulatory violations.

Unlike general software localization, life sciences applications require highly specialized translations to ensure clarity and accuracy in medical terminology, dosage instructions, device settings, and clinical trial data. Any linguistic error can lead to misinterpretation, incorrect treatment, or compliance risks, making subject-matter expertise critical.

Localized software must offer intuitive, culturally adapted interfaces that enhance usability for healthcare providers, researchers, and patients. This includes right-to-left language support, character expansion handling, and localized date, time, and measurement formats to maintain a seamless experience across languages and regions.

Errors in medical software localization can result in misdiagnoses, incorrect prescriptions, or regulatory noncompliance, posing serious health risks and legal consequences. Robust linguistic validation, functional testing, and in-country reviews help ensure that localized software functions accurately and meets regulatory and patient safety standards in all languages.

With deep industry expertise and a quality-driven localization process, Sesen helps life sciences companies deliver fully compliant, linguistically precise, and user-friendly software solutions for global markets.

Our Software Localization Capabilities

At Sesen, we combine specialized life sciences expertise with comprehensive localization services to deliver precise, compliant, and user-friendly software solutions. Our team utilizes advanced localization technologies and maintains a global network of in-country linguists, ensuring that your software resonates with local audiences while meeting all regulatory requirements.

  • Regulatory Compliance: We ensure all localized software adheres to regional regulatory standards, including FDA, EMA, CFDA, and PMDA guidelines, facilitating smooth market entry and compliance.​
  • Medical Subject-Matter Expertise: Our translators possess backgrounds in pharmaceuticals, biotechnology, and healthcare IT, enabling precise translation of complex medical content. ​
  • Human Factors and Usability Testing: We conduct rigorous usability testing to ensure that localized software is both intuitive and medically accurate, enhancing user experience and patient safety. ​
  • Translation & Linguistic Validation: Our process ensures translations are both accurate and culturally appropriate, maintaining the integrity of medical information across languages. ​
  • Software UI Adaptation: We address technical aspects such as character limitations, bidirectional text, and UI string truncation to ensure seamless functionality in all target languages. ​
  • Content Extraction and Re-Integration: Our engineering team expertly handles the extraction, translation, and reintegration of software content, preserving functionality and user experience.
  • Multilingual Testing & Quality Assurance (QA): We perform comprehensive functional, linguistic, and regulatory testing to ensure the localized software meets all necessary standards and performs flawlessly. ​
  • Regulatory Review Support: We collaborate with in-country regulatory bodies to ensure all software documentation complies with local requirements, facilitating a smooth approval process. ​

By integrating specialized subject matter expertise with comprehensive language services, Sesen delivers accurate, compliant, and user-friendly software localization solutions for the life sciences industry.

Supported Life Sciences Software & Applications

In the life sciences industry, software and applications must be precisely localized to meet regulatory standards, ensure user safety, and provide an intuitive experience across diverse markets. Sesen specializes in localizing a wide array of life sciences software, adhering to industry best practices and leveraging our deep sector expertise.​

eClinical applications are pivotal in managing clinical trials and data collection. Sesen ensures these platforms comply with regional regulations, translating complex medical terminology accurately and adapting user interfaces to align with local cultural norms. Our best practices include:​

  • Regulatory Compliance: Adhering to standards set by authorities like the FDA and EMA to ensure data integrity and patient safety.​
  • User-Centric Design: Modifying interfaces to accommodate language-specific nuances, enhancing usability for diverse user groups.​

For medical devices and their companion apps, precise localization is crucial to ensure proper functionality and user safety. Sesen’s approach involves:​

  • Compliance with Regulatory Standards: Ensuring that all localized content meets regional regulatory requirements to avoid legal issues and product recalls. ​
  • Technical Adaptation: Adjusting software to support different character sets and text directions, ensuring seamless operation across languages.​

Patient-facing applications and wearables require localization to provide accurate health information and user-friendly interfaces. Sesen’s solutions include:​

  • Cultural Sensitivity: Adapting content to respect cultural nuances, ensuring relevance and comfort for users.​
  • Regulatory Adherence: Ensuring compliance with local regulations to maintain user trust and meet legal obligations. ​

Localization of regulatory and compliance software is essential for global operations. Sesen ensures:​

  • Accurate Translation: Precisely translating regulatory terminology to maintain compliance and avoid legal pitfalls.​
  • Functional Integrity: Testing localized software to ensure all features operate correctly in the target language.​

Enterprise Resource Planning (ERP) and Laboratory Information Management Systems (LIMS) in pharmaceuticals and biotech sectors require meticulous localization. Sesen’s approach includes:​

  • Terminology Management: Maintaining consistency in specialized terminology across all localized materials.​
  • Process Alignment: Ensuring that localized software aligns with local business practices and regulatory requirements.​

Electronic Health Records (EHR) and Electronic Medical Records (EMR) systems must be localized to ensure accurate patient information management.Sesen focuses on:​

  • Data Privacy Compliance: Adapting systems to comply with local data protection laws, safeguarding patient information.​
  • User Training: Providing localized training materials to ensure healthcare professionals can effectively use the systems.​

By implementing these tailored localization strategies, Sesen ensures that life sciences software and applications are compliant, user-friendly, and effective across global markets.

Optimizing Life Sciences Software Localization

Effective localization is essential for life sciences software to ensure regulatory compliance, enhance user experience, and facilitate global reach. Sesen employs industry best practices to deliver precise and culturally appropriate localized solutions.​

We assist clients in preparing their software for localization by:​

  • Decoupling Localizable Elements: Ensuring text and cultural components are separate from core code to allow seamless adaptation.​
  • Implementing Unicode Standards: Supporting diverse character sets to accommodate various languages.​

Our structured workflows address the stringent requirements of the life sciences industry:​

  • Regulatory Alignment: Ensuring localized content complies with regional regulations, facilitating market entry.​
  • Cultural Adaptation: Modifying content to resonate with local cultural norms and medical practices, enhancing relevance and acceptance.​

We engage native-speaking medical experts to review localized software, ensuring:​

  • Linguistic Accuracy: Precise translation of medical terminology to maintain clarity and prevent misinterpretation.​
  • User-Centric Design: Interfaces that are intuitive and culturally appropriate, improving usability for healthcare professionals and patients.​

In agile software development, rapid iteration and frequent updates are standard. To align localization efforts with this pace, Sesen implements continuous localization strategies. By integrating localization processes directly into development sprints, we ensure that translations occur concurrently with code development. This synchronization allows for simultaneous updates across all languages, maintaining consistent user experiences and significantly reducing time-to-market. Such an approach ensures that localized versions of the software are always up-to-date, facilitating seamless global releases and enhancing overall efficiency. ​

To enhance the quality and efficiency of our localization efforts, Sesen employs automated linguistic testing tools. By integrating these tools into our development process, we can swiftly identify and rectify linguistic inconsistencies, functional issues, and cultural inaccuracies. This proactive approach not only minimizes errors but also accelerates time-to-market, ensuring that our localized software delivers a seamless and intuitive user experience across diverse languages and regions.​

By integrating these best practices seamlessly into our software l10n projects, Sesen ensures that localized life sciences software is compliant, user-friendly, and ready for global deployment.

Why Choose Sesen for Software Localization?

Sesen excels in software and app localization for the life sciences industry, offering a comprehensive suite of services tailored to the unique demands of pharmaceutical, biotech, and medical device sectors.​

Our deep expertise in these industries allows us to navigate complex regulations, ensuring all localized content meets stringent standards and maintains scientific and regulatory accuracy.​

We assign dedicated project managers to each client, providing weekly status updates and coordinating regulatory reviews. This structured approach ensures projects stay on track, regulatory requirements are thoroughly addressed, and localization workflows are optimized for efficiency and accuracy.​

Our team comprises certified linguists, experienced localization engineers, and regulatory specialists. This global network enables us to handle projects of any scale and complexity, delivering culturally and linguistically accurate translations that resonate with target audiences.​

Leveraging SesenGPT, our proprietary large language models (LLMs), automated workflows, and advanced linguistic Quality Assurance (QA) tools, we offer scalable solutions that enhance efficiency and accuracy. These AI-powered tools streamline complex localization workflows, enabling faster turnaround times while maintaining linguistic and regulatory precision.​

Our commitment to quality is underscored by our certifications, including ISO 17100, ISO 9001:2015, and ISO 13485:2016. These certifications reflect our adherence to international standards, ensuring our localization services meet the highest levels of quality and reliability.​

We collaborate with in-country regulatory bodies and compliance teams to ensure localized software meets market-specific submission requirements. This includes adapting regulatory labels, safety warnings, and documentation to align with regional standards.​

By integrating specialized industry knowledge with advanced technologies and a global team of experts, Sesen delivers localization services that are precise, compliant, and tailored to the unique needs of the life sciences industry.

Case Studies & Success Stories

Sesen partnered with a U.S.-based clinical research organization to adapt their Clinical Trial Management System (CTMS) for a specific drug development program targeting European markets. Our team ensured compliance with the European Union Clinical Trials Regulation (EU-CTR), which harmonizes the assessment and supervision processes of clinical trials across the EU. We addressed linguistic and cultural nuances across regions, implementing robust internationalization (i18n) practices to enable seamless integration of various European languages and date formats. This comprehensive localization facilitated efficient clinical trial management and data collection, aligning with regional requirements and supporting the successful progression of the drug development program.

A medical device manufacturer sought Sesen’s expertise to localize their software for Asian and European markets. Our team meticulously translated user interfaces, instructional content, and compliance documentation, ensuring adherence to the European Union’s Medical Device Regulation (MDR) and specific Asian country regulations. By implementing in-context translation solutions, we significantly reduced the need for extensive localization testing, such as linguistic and cosmetic assessments, thereby streamlining the deployment process and enhancing overall efficiency. ​

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Partner with Sesen for expert software localization services in the life sciences sector. We offer tailored solutions to meet your specific needs.

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