Terminology Management in Life Sciences

Ensuring linguistic precision and regulatory consistency across global markets

The Role of Terminology in Life Sciences Translation

In the highly regulated life sciences industry, accurate and consistent terminology is essential. From clinical trial protocols and regulatory submissions to patient-facing materials and software interfaces, the correct use of terms ensures clarity, minimizes risk, and supports global compliance. As life sciences companies expand into international markets, the demand for multilingual content that preserves the intended meaning of highly technical terms becomes even more critical.

Inconsistent or incorrect terminology can lead to serious consequences, including regulatory delays, product recalls, miscommunication with healthcare professionals, and confusion among patients. A mistranslated dosage instruction or an ambiguous term in an informed consent form can compromise not only the success of a study but also patient safety and trust.

This blog explores why terminology management is a foundational element of life sciences translation. It outlines best practices for glossary development, discusses applicable regulatory and quality standards, and highlights how structured terminology workflows reduce risk and improve translation accuracy. It also provides an inside look at Sesen’s specialized approach to terminology management, developed to help clients maintain linguistic precision across clinical, regulatory, and commercial content at global scale.

Why Terminology Management Matters in Life Sciences

Effective terminology management is critical in ensuring linguistic precision, regulatory compliance, and clear communication throughout the product lifecycle. In life sciences, even minor inconsistencies in terminology can introduce risk, delay approvals, and compromise patient safety.

Precision in Clinical and Regulatory Content

Accurate terminology is essential for conveying complex medical, scientific, and procedural concepts without ambiguity. Whether drafting clinical protocols, investigator brochures, or regulatory submissions, precise language prevents misinterpretation by investigators, ethics committees, and regulatory authorities. Misused or inconsistent terms can trigger requests for clarification, introduce compliance risks, or lead to misaligned expectations across study teams.

Ambiguous terminology is a common cause of regulatory delays. Agencies such as the FDA and EMA expect consistent terminology aligned with recognized standards. Documents that use interchangeable terms without definition or alignment may be flagged during review, requiring rework that slows down time to approval.

Global Consistency Across Locales

Terminology management also plays a vital role in multilingual translation workflows. As life sciences organizations expand into international markets, maintaining equivalent meaning across languages becomes a key quality requirement. Without structured terminology processes, translated materials can drift from source intent, leading to clinical misunderstandings, commercial misbranding, or regulatory noncompliance.

In addition to linguistic accuracy, terminology must align with local regulatory frameworks. For example, translations intended for the European Medicines Agency (EMA) must follow QRD template requirements, while submissions to the U.S. Food and Drug Administration (FDA) often use Structured Product Labeling (SPL) formats. Proper terminology management ensures consistent use of agency-approved terms, increasing acceptance and minimizing the risk of revision requests.

Key Components of Life Sciences Terminology Management

Terminology management in life sciences requires more than just a list of approved terms. It involves structured systems and documentation that support clarity, compliance, and consistency across all content types. Two foundational tools—glossaries and style guides—form the backbone of any effective terminology program.

Glossaries

Glossaries are curated, centralized repositories of approved terms that support consistent and accurate translation. In life sciences, glossaries are often bilingual or multilingual to reflect the needs of global stakeholders. Each term entry typically includes the source term, approved translation(s), part of speech, definition, usage context, and approval status. Additional metadata such as domain specificity or notes for translators can further improve relevance and usability.

Well-maintained glossaries reduce ambiguity, support alignment across departments, and enable faster and more accurate translation. They are especially critical in high-risk documents such as clinical trial protocols, labeling, investigator brochures, and safety data sheets where precision is non-negotiable.

Style Guides

While glossaries ensure consistent terminology, style guides govern how language should be used across content types. A comprehensive style guide for life sciences covers tone of voice, grammar preferences, punctuation rules, and formatting standards. It also addresses language variants—such as US versus UK English—and defines how to handle acronyms, abbreviations, and units of measure.

Importantly, style guides also define preferred versus forbidden terminology, helping linguists navigate the nuances of scientific clarity versus patient readability. For example, a patient-facing translation may favor simplified language over dense clinical terms, while regulatory documents require strict adherence to approved technical expressions.

Together, glossaries and style guides enable life sciences companies to produce content that is accurate, regulatory-ready, and tailored for the intended audience—whether that is a global regulator, clinical researcher, or patient.

Industry Standards and Regulatory Expectations

Terminology management in life sciences is not just a best practice—it is a critical compliance requirement driven by global regulatory standards. Health authorities and industry frameworks place significant emphasis on linguistic consistency, accuracy, and traceability throughout the translation process. Understanding these expectations helps life sciences companies reduce risk and avoid costly delays.

EMA’s Quality Review of Documents (QRD) Templates

The European Medicines Agency (EMA) mandates the use of QRD templates for product information documents, such as summaries of product characteristics (SmPCs), package leaflets, and labeling. These templates enforce standard wording and terminology to ensure consistency across EU member states and facilitate multilingual review. Translators must adhere strictly to QRD-prescribed terms and formatting, leaving no room for variation. Failure to comply can result in rejections or prolong the review cycle.

ISO 17100: Translation Services – Requirements for Translation Processes

ISO 17100 sets the global benchmark for translation quality and defines the requirements for all stages of the translation workflow, including terminology management. It mandates the use of verified resources such as client-approved glossaries and style guides, and requires qualified linguists to apply these resources consistently. Adhering to ISO 17100 helps organizations meet quality assurance expectations and demonstrates a systematic approach to translation control.

ISO 9001 and ISO 13485 Implications for Terminology Consistency

ISO 9001 and ISO 13485 focus on quality management systems and are especially relevant to medical device manufacturers and regulated service providers. Both standards emphasize process control, risk management, and documentation accuracy. Inconsistent terminology across translated technical files, instructions for use (IFUs), or labeling materials can compromise product integrity and trigger compliance audits. A robust terminology management process supports ongoing certification and regulatory alignment under these standards.

Considerations for FDA, PMDA, and NMPA Submissions

Regulatory authorities such as the FDA (United States), PMDA (Japan), and NMPA (China) each have unique language, formatting, and documentation requirements. Inconsistent terminology across submission documents can raise red flags and result in queries, delays, or non-acceptance. For example, the FDA’s Structured Product Labeling (SPL) format requires consistent use of coded terminology aligned with medical vocabularies such as MedDRA or SNOMED CT. Similarly, Japan’s PMDA and China’s NMPA require culturally and linguistically adapted terms that remain faithful to the source while complying with local technical expectations.

By aligning terminology management practices with international standards and regulatory guidance, life sciences companies can streamline global submissions, reduce risk, and enhance the overall quality of multilingual documentation.

Best Practices for Effective Terminology Management

Implementing a terminology management strategy that is both scalable and compliant requires more than simply compiling a list of terms. It involves coordinated processes, stakeholder engagement, and the use of specialized tools to maintain accuracy and alignment across multilingual content. The following best practices help life sciences organizations establish a structured, quality-focused approach to terminology management.

Collaboration Between Linguists and Subject Matter Experts (SMEs)

Effective terminology management depends on collaboration between professional linguists and internal subject matter experts. Regulatory affairs teams, clinical scientists, medical writers, and translators must work together to validate terminology that is not only linguistically correct but also medically and scientifically accurate. SMEs provide domain-specific insights that ensure terminology aligns with regulatory expectations, therapeutic area conventions, and company-preferred usage. This cross-functional alignment is essential for regulatory documentation, safety communications, and product labeling.

Version Control and Approval Workflows

Maintaining centralized and up-to-date term databases is critical to preventing inconsistencies across translations. Each term should be versioned and linked to an audit trail showing when and by whom it was added, modified, or approved. Implementing structured approval workflows ensures that terms are reviewed and validated by relevant stakeholders before being used in live projects. This process supports traceability, minimizes rework, and aligns with quality assurance frameworks such as ISO 9001 and ISO 17100.

Term Extraction from Source Materials

Identifying high-impact terminology begins with the systematic extraction of terms from source documents. Using AI and machine learning algorithms or computer-assisted translation (CAT) tools, teams can automatically extract recurring terms from clinical trial protocols, investigator brochures (IBs), summaries of product characteristics (SmPCs), instructions for use (IFUs), and other key documents. Once extracted, terms can be analyzed for frequency, relevance, and consistency, and added to a master glossary for downstream use. This proactive approach reduces ambiguity, improves translation speed, and ensures alignment across related documents and teams.

By applying these best practices, life sciences organizations can elevate translation quality, reduce regulatory risk, and improve collaboration across departments and geographies. A well-managed terminology framework is not just a linguistic asset—it is a strategic advantage in today’s global life sciences environment.

Tools and Technologies for Scalable Terminology Management

Technology plays a vital role in ensuring terminology consistency across complex, multilingual life sciences content. Modern tools not only streamline workflows but also help reduce human error, improve quality, and support compliance with international standards. The following technologies are essential components of an effective terminology management ecosystem.

Computer-Assisted Translation (CAT) Tools

CAT tools are foundational to professional translation workflows. These platforms offer built-in termbases that enable translators to access approved terminology in real time as they work. As the translator types, the system automatically suggests terms from the glossary that match the source content, helping enforce consistency across segments and files. Many CAT tools also highlight term mismatches during quality assurance checks, reducing the risk of deviation from approved language. This functionality is especially important in regulatory and clinical content, where even a small variation can result in compliance issues or misunderstanding.

Terminology Management Systems (TMS Integration)

Advanced translation management systems (TMS) allow centralized storage and access to terminology resources. By integrating glossaries directly into the TMS, life sciences organizations ensure that linguists, reviewers, project managers, and even clients are working from a single source of truth. These systems often support access control, version history, and approval workflows, which are critical for maintaining consistency in high-volume or multi-market projects. Centralized access also reduces duplication of effort and makes it easier to align terminology across cross-functional teams.

AI-Enhanced Glossary Development

Artificial intelligence is increasingly being used to automate and optimize glossary creation and maintenance. AI-powered tools can recognize and classify recurring termsfrom source documents using natural language processing, significantly speeding up the glossary development process. These tools can also make predictive term suggestions by analyzing large parallel corpora, identifying preferred equivalents, and flagging terminology gaps. When used strategically, AI helps ensure that glossaries remain accurate, relevant, and up to date as new terms emerge and products evolve.

By combining traditional linguistic tools with AI-driven automation and centralized systems, Sesen supports its clients with a modern, scalable approach to terminology management that improves efficiency, reduces regulatory risk, and drives translation quality across every stage of the life sciences content lifecycle.

Real-World Use Cases

Effective terminology management delivers measurable impact across a wide range of life sciences content types. Whether for regulatory documentation, patient communications, or digital health platforms, consistent terminology supports compliance, improves clarity, and accelerates time to market. The following use cases illustrate how Sesen applies best practices to help clients solve real-world challenges.

Case 1: Regulatory Submissions for a Global Biopharma

A multinational biopharmaceutical company preparing simultaneous submissions to the European Medicines Agency (EMA) and regulatory agencies in Japan and South Korea needed to harmonize terminology across all regions. The challenge was ensuring that product-specific terms, indications, and adverse event descriptions remained consistent across different language versions while meeting each market’s regulatory expectations.

Sesen developed a multilingual terminology framework aligned with EMA’s QRD templates and APAC regulatory requirements. Our team built region-specific glossaries and integrated them into our TMS, enabling linguists across markets to apply consistent terms during translation. This approach reduced back-and-forth during agency reviews and supported faster approvals in all targeted regions.

Case 2: Patient-Facing Materials for Rare Disease Trials

A rare disease sponsor needed to translate a suite of informed consent forms, dosing instructions, and educational brochures for a multinational Phase III trial. The materials needed to strike a balance between clinical accuracy and readability for a general patient population with limited familiarity with medical terminology.

Sesen worked with the client’s clinical and patient engagement teams to define preferred terminology that retained scientific integrity while improving comprehension. We developed a patient-friendly glossary in multiple languages, conducted readability testing with native speakers, and applied consistent language across all trial documents. The result was greater patient understanding and increased confidence among site staff managing participant interactions.

Case 3: Software UI Localization for a Digital Health Platform

A digital health company was localizing its mobile platform into ten languages for global rollout. Terminology challenges included maintaining concise, functional terms within strict character limits while preserving medical accuracy and aligning with back-end database labels.

Sesen collaborated with the client’s UX and development teams to build a localization-ready glossary that aligned with both clinical standards and technical requirements. We mapped translated terms to interface constraints, ensured consistency across user prompts and settings, and implemented real-time term validation within our CAT tools. This ensured a seamless user experience across languages while maintaining regulatory alignment for medically sensitive content.

Sesen’s Approach to Terminology Management

At Sesen, terminology management is not an afterthought, it is a strategic service built into every stage of the translation lifecycle. Our approach combines linguistic expertise, regulatory knowledge, and cutting-edge technology to help life sciences organizations achieve accuracy, compliance, and global consistency across all content types.

Custom Glossary and Style Guide Development

We begin by creating tailored glossaries and style guides that reflect each client’s unique products, regulatory requirements, and communication goals. Our terminology specialists collaborate with client teams to extract key terms from source documents, define context-specific meanings, and standardize translations across target languages. Style guides are customized to align with brand tone, regional language variants, and document types, whether regulatory, clinical, or patient-facing.

Integrated QA Checks During and After Translation

Our translation workflows incorporate built-in quality assurance checks that reference approved glossaries in real time. Using advanced CAT tools, we automatically flag any deviations from client-approved terminology to maintain consistency throughout the project. Post-translation, we conduct terminology-specific reviews to validate term usage, ensuring every deliverable meets the highest standards for accuracy and regulatory alignment.

Ongoing Glossary Maintenance and Stakeholder Feedback Loops

Terminology in life sciences is dynamic. New terms emerge as products evolve and regulations are updated. Sesen supports continuous glossary maintenance, incorporating feedback from reviewers, regulatory affairs teams, and in-country stakeholders. Our terminology databases are version-controlled and fully auditable, helping clients maintain long-term consistency while adapting to change.

Onboarding New Clients with Terminology Audits and Baseline Alignment

For new engagements, Sesen conducts a terminology audit to assess existing content, identify inconsistencies, and establish a baseline for future translations. This includes evaluating legacy glossaries, previously translated materials, and client-specific terminology preferences. We then build a centralized terminology framework to guide future projects and improve efficiency, quality, and turnaround time from day one.

By embedding terminology governance into every client relationship, Sesen delivers more than just translation, we provide a scalable framework for clear, compliant, and consistent multilingual communication in life sciences.

Benefits of Partnering with Sesen

Partnering with Sesen for terminology management offers life sciences organizations a clear competitive advantage. Our structured approach helps clients achieve greater accuracy, faster delivery, and stronger compliance across multilingual content. The following are key benefits of working with our specialized team.

Improved Translation Quality and Turnaround Time

By integrating terminology resources into our translation workflows, Sesen reduces ambiguity and ensures greater consistency across projects. Translators work with pre-approved termbases and style guides, enabling them to deliver high-quality output more efficiently. This minimizes the need for rework and accelerates turnaround times without compromising precision.

Fewer Client Review Cycles Due to Upfront Term Alignment

Clear and consistent terminology from the start reduces the burden of post-translation review. Our team aligns terminology with client preferences and regulatory requirements before translation begins, which leads to smoother validation and fewer rounds of revision. This saves time for internal teams and improves the overall experience for stakeholders.

Reduced Regulatory Risk and Higher Market Acceptance

Accurate terminology is essential for meeting the expectations of global health authorities such as the FDA, EMA, PMDA, and NMPA. Our terminology management practices help ensure that translated content aligns with agency standards, reducing the risk of regulatory findings or submission delays. In commercial contexts, clear and consistent language also increases brand credibility and improves acceptance by healthcare professionals and patients.

Support for 150 Languages with Domain-Specialized Linguists

Sesen supports translation in more than 150 languages, with linguists who are not only native speakers but also subject matter experts in fields such as pharmaceuticals, biotechnology, medical devices, and digital health. Our global team applies terminology consistently across regions, ensuring that localized content is both culturally appropriate and scientifically accurate.

With Sesen, clients gain a trusted partner that delivers reliable terminology management tailored to the unique demands of the life sciences industry.

Moving Forward with Strategic Terminology Management

As life sciences organizations expand globally, the need for structured terminology management has become more critical than ever. Clear, consistent terminology enhances translation quality, reduces regulatory risk, and improves communication across clinical, regulatory, and commercial content. It also strengthens brand trust and speeds up product launches by minimizing ambiguity and revision cycles.

Sesen brings deep expertise in life sciences translation and a proven track record of supporting global companies with terminology solutions tailored to their unique workflows and content types. From custom glossary development and integrated QA to ongoing terminology governance, we provide a comprehensive approach that scales with your needs.

If your organization is seeking greater accuracy, efficiency, and control over multilingual content, Sesen is ready to help. Our team can support you with terminology audits, glossary alignment, and scalable solutions designed for regulatory success and global market reach.

Get Expert Terminology Support for Global Life Sciences Content

Take the next step toward streamlined, compliant, and scalable multilingual content with Sesen’s terminology solutions. Sesen helps life sciences companies build a strong terminology foundation for regulatory, clinical, and patient-facing content. From audits to glossary development and ongoing management, our team ensures clarity, consistency, and compliance across languages.

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