Meet Sesen at DIA 2025 in Washington, D.C.
Join us June 15–19 at Booth #2013 to explore global clinical and regulatory language solutions.
Terminology Management & Harmonization
Consistent scientific and brand language across all markets, backed by expert-driven terminology governance and multilingual alignment.
Sesen provides centralized terminology management and harmonization solutions tailored for the life sciences industry—ensuring regulatory precision, higher translation quality, and faster time to market. Our approach standardizes preferred terms and ensures consistent usage across languages, regions, and content types.
Why Terminology Matters in Life Sciences
In today’s highly regulated and globally distributed life sciences environment, maintaining linguistic consistency across markets is a critical challenge. As companies expand internationally and generate content in multiple languages and formats—spanning clinical trials, regulatory filings, product labeling, and marketing—terminology discrepancies can lead to regulatory delays, patient safety risks, and brand inconsistency.
Clear, controlled terminology is essential for ensuring that scientific concepts, product information, and brand messaging are communicated accurately and unambiguously across all languages. From drug names and indications to procedural descriptions and safety warnings, precise language supports regulatory compliance, facilitates health authority reviews, and builds trust with patients, providers, and partners.
The growing complexity of product pipelines, along with the integration of AI-driven translation technologies, has only increased the need for robust terminology management. Without a centralized, harmonized approach, inconsistencies can proliferate across content types and geographies—compromising quality, compliance, and efficiency.
At Sesen, we address these challenges through structured, technology-enabled terminology solutions designed specifically for life sciences organizations operating on a global scale.
Read More Read Less
What Is Terminology Management?
Terminology management is the structured process of creating, maintaining, and applying a centralized set of preferred terms, synonyms, abbreviations, and controlled vocabulary across all content types and languages. In life sciences, this includes scientific terms, regulatory references, product names, dosage forms, and medical conditions—all of which must be used consistently to ensure clarity, compliance, and safety.
Integrated into translation and localization workflows, terminology management enables our linguists, subject matter experts, and regulatory teams to work from a shared, validated reference—often maintained in a terminology database or glossary. This centralization reduces the risk of misinterpretation, accelerates translation timelines, and improves content accuracy at scale.
For example, enforcing the use of “myocardial infarction” instead of the more general “heart attack” in clinical trial protocols ensures scientific precision and aligns with regulatory expectations. Similarly, standardized terminology across labeling and patient-facing materials minimizes ambiguity and supports better health outcomes.
At Sesen, we implement terminology management as a foundational component of every localization program—customized to reflect your organization’s linguistic standards, therapeutic areas, and compliance requirements.
Read More Read Less
What Is Linguistic Harmonization?
Linguistic harmonization is the process of aligning terminology usage and language expression across languages, geographic regions, and internal departments to achieve consistency in meaning, tone, and regulatory acceptability. In life sciences, this practice is critical for ensuring that scientific, regulatory, and marketing content communicates uniformly across global markets—regardless of language or audience.
Harmonization is widely applied in areas such as clinical research (e.g., patient-facing documents and investigator brochures), regulatory submissions, product labeling, and commercial materials, where inconsistent language can create confusion or delay approvals. It also plays a key role in the reconciliation of dual forward translations in linguistic validation workflows, ensuring that the final version accurately reflects source intent while meeting local linguistic expectations.
While standardization involves defining and enforcing a single preferred term or phrase, harmonization focuses on resolving linguistic variation by aligning equivalent expressions across regions or content types. For example, ensuring that the translated term for “adverse event” maintains the same regulatory nuance across EU, U.S., and APAC markets—even when rendered differently in each language.
At Sesen, linguistic harmonization is built into our localization framework to support cross-market consistency, reduce ambiguity, and enhance the clarity and compliance of multilingual content across all stages of the product lifecycle.
It’s worth noting that the term harmonization is also used in other life sciences localization contexts—such as linguistic validation, where it refers to reconciling two independently translated versions of a clinical instrument. While this page focuses on harmonization for terminology and multilingual content consistency, we offer broader harmonization solutions as well.
Read More Read Less
Benefits of Unified Terminology and Harmonization
A consistent approach to terminology management and linguistic harmonization delivers significant advantages across the life sciences content lifecycle—from regulatory submissions to patient-facing materials.
Regulatory Compliance Across Markets
Unified terminology supports adherence to global and regional regulatory standards, including those set by the FDA, EMA, PMDA, and other health authorities. Standardized, validated language helps minimize ambiguity in clinical and technical content, reducing the likelihood of rejections or clarification requests.
Accelerated Review and Approval Timelines
By aligning terminology across all documentation, companies can shorten review cycles with regulatory bodies. Harmonized language streamlines cross-functional content development and facilitates faster responses to authority queries.
Fewer Translation Errors and Quality Issues
A controlled vocabulary and consistent terminology reduce the risk of mistranslation, omission, or inconsistent phrasing—particularly in complex scientific and regulatory contexts. This leads to more reliable and accurate translations throughout multilingual workflows.
Enhanced Machine Translation and Post-Editing Efficiency
Terminology alignment improves the performance of machine translation engines by training them on standardized input. As a result, post-editors work more efficiently, and output quality is significantly improved—especially for repetitive or structured content.
Stronger Brand Trust and Scientific Credibility
Consistent scientific and brand language across regions reinforces your company’s credibility with regulators, healthcare professionals, and patients. Harmonized terminology ensures that your messaging remains precise, professional, and aligned with your therapeutic and corporate voice.
Our Approach at Sesen
Sesen’s terminology management and harmonization framework is designed specifically for the complexities of global life sciences communication. We combine linguistic expertise with intelligent workflows and client collaboration to ensure scalable, high-quality outcomes across all content types and languages.
Cross-Functional Collaboration
We work closely with your internal stakeholders—subject matter experts (SMEs), regulatory reviewers, and in-country translators—to validate terminology and ensure accuracy, compliance, and regional relevance. This collaborative model strengthens scientific credibility and regulatory readiness.
Technology-Enabled Workflows
Our approach integrates seamlessly with industry-standard computer-assisted translation (CAT) tools and translation management systems (TMS) to automate term enforcement and streamline project execution. This enables consistent application of approved terminology across multilingual content at scale.
Multilingual Termbase Development
We create and maintain centralized, multilingual termbases and glossaries tailored to your therapeutic areas, product portfolios, and regulatory landscapes. Our glossary alignment workflows ensure terminology is consistently applied across clinical, regulatory, and commercial documentation.
Governance and Lifecycle Management
Sesen implements structured terminology governance models, including term approval processes, change tracking, version control, and stakeholder feedback loops. This ensures your terminology assets remain current, validated, and adaptable to evolving product or regulatory needs.
Regional Harmonization and Alignment
We actively harmonize terminology across regions, affiliates, and departments to reduce inconsistencies and support cross-market alignment. Whether localizing content for APAC, EMEA, or LATAM regions, our processes ensure consistency in terminology use, tone, and scientific expression.
Sesen’s Terminology Management & Harmonization Workflow
At Sesen, our process blends advanced technology with linguistic expertise to manage terminology efficiently and at scale. Here’s how we ensure context-aware, high-quality terminology across all content types and languages:
Context-Aware Term Extraction
We use AI-powered tools to extract terminology from source documents, identifying scientific terms, abbreviations, and domain-specific language based on usage frequency and context. This enables faster glossary development while preserving linguistic nuance.
Human Linguist and SME Validation
Extracted terms undergo review by professional linguists and in-country subject matter experts (SMEs) to ensure scientific accuracy, regulatory alignment, and cultural relevance. We validate definitions, usage, and translations before approval.
Multilingual Glossary Creation
Approved terms are compiled into centralized, multilingual glossaries and termbases, aligned with product portfolios, therapeutic areas, and regional preferences. These glossaries are made accessible across your translation ecosystem.
Integration with CAT Tools and TMS
We integrate terminology assets into your preferred CAT tools and translation management systems to enforce term usage and enable real-time glossary lookups during localization. This improves translator productivity and consistency.
Harmonization and Cross-Market Review
Our QA linguists conduct harmonization checks to ensure alignment across regions and departments. This includes resolving discrepancies in terminology usage across clinical, regulatory, labeling, and commercial content.
Ongoing Governance and Maintenance
We implement terminology lifecycle management protocols, including stakeholder feedback loops, version control, and periodic updates to reflect evolving regulatory language or product changes.
Use Cases and Applications
Sesen’s terminology management and harmonization solutions are integrated into every stage of life sciences content development, supporting precise communication, regulatory compliance, and cross-market consistency. Our services are tailored to meet the specific needs of pharmaceutical, biotechnology, medical device, and CRO clients across the following use cases:
Regulatory Submissions
Accurate and consistent terminology is critical for global submissions such as INDs, NDAs, and CTD dossiers. Harmonized language across submission components ensures clarity for health authorities and reduces the risk of delays due to terminology inconsistencies.
Clinical Trial Documentation
We apply validated terminology across clinical protocols, investigator brochures, and informed consent forms (ICFs) to ensure scientific precision and patient comprehension. Consistent language helps streamline ethics board approvals and enhances data integrity.
Labeling, IFUs, and Packaging Content
Sesen standardizes terminology for instructions for use (IFUs), drug labeling, and packaging materials, helping clients meet regulatory and linguistic requirements in each target market. Harmonization reduces ambiguity and enhances patient safety.
eLearning Modules and Patient-Facing Content
For training materials and patient communications, we ensure simplified, consistent terminology that supports comprehension while maintaining scientific accuracy. This includes digital content, onboarding tools, and adherence resources.
Software and Digital Health Localization
We manage terminology across life sciences software—including clinical platforms, diagnostic tools, and mobile health apps—ensuring alignment between UI strings, help documentation, and regulatory content across all supported languages.
Standards and Compliance
At Sesen, our terminology management and harmonization practices are built around internationally recognized standards to ensure regulatory readiness, linguistic precision, and data security across all project workflows.
ISO 17100-Certified Workflows
Our processes comply with the ISO 17100:2015 standard for translation services, ensuring structured terminology management, qualified linguist involvement, and consistent quality control across all language pairs. This certification reinforces our commitment to delivering accurate and verifiable linguistic output for regulated life sciences content.
Alignment with Industry Terminology Standards
We align terminology assets with globally recognized medical and scientific coding systems, including:
- MedDRA (Medical Dictionary for Regulatory Activities)
- EDQM (European Directorate for the Quality of Medicines)
- SNOMED CT (Systematized Nomenclature of Medicine – Clinical Terms)
- WHO-DD (World Health Organization Drug Dictionary)
These integrations ensure consistency with regulatory expectations, support pharmacovigilance, and enhance the semantic accuracy of clinical and safety documentation.
Data Security and Privacy Compliance
Sesen adheres to strict data protection protocols in accordance with GDPR, HIPAA, and client-specific confidentiality agreements. Our terminology systems and translation platforms are hosted on secure, access-controlled environments to safeguard sensitive scientific and patient information.
Accelerating Regulatory Review Through Terminology Harmonization
— A Client Success Story
A leading global biopharmaceutical company partnered with Sesen to standardize and harmonize terminology across its multilingual clinical trial documentation and regulatory submission materials. The client was preparing simultaneous submissions to the FDA, EMA, and PMDA, and faced inconsistencies in terminology usage across regions and functional departments.
Sesen implemented a centralized multilingual termbase and collaborated with the client’s Regulatory Affairs, Clinical, and Localization teams to align terminology across all modules of the Common Technical Document (CTD). This included reconciling discrepancies in medical conditions, dosage forms, and safety terminology.
Results:
- 30% reduction in review cycle revisions from global health authorities
- 25% faster turnaround in localization of submission materials
- Improved translation consistency across 12 language pairs
- Enhanced reviewer confidence and smoother regulatory feedback loop
This project highlights how terminology governance and linguistic harmonization can drive tangible operational and regulatory outcomes in complex, global product launches.
Read More Read Less
Take the First Step Toward Terminology Consistency
Ready to unify your scientific and regulatory terminology across global markets? Whether you’re launching a new product, preparing for regulatory submissions, or optimizing multilingual content workflows, Sesen can help you build a centralized, compliant, and scalable terminology framework.