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Quality Is Not Optional. It Is Regulatory, Clinical, and Ethical

In life sciences, quality assurance is not a formality. It is a critical safeguard that protects patient safety, supports regulatory compliance, and preserves scientific credibility. A single translation error in an informed consent form, labeling component, or clinical study protocol can lead to delayed approvals, product recalls, or compromised trial data.

Quality assurance in translation ensures consistency, accuracy, and alignment with both global regulatory standards and local market expectations. It enables traceable documentation, transparent workflows, and risk mitigation across the full content lifecycle.

At Sesen, quality is not a step at the end. It is a fully integrated system embedded in every stage of our translation process. From linguist selection and terminology control to automated QA tools and back-validation, every measure is designed to uphold precision, compliance, and trust.

Our clients operate in high-stakes environments where quality is not negotiable. That is why leading pharmaceutical companies, biotech firms, medical device manufacturers, and CROs trust Sesen to deliver linguistically accurate and regulator-ready translations every time.

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A Systematic, Multi-Tiered QA Process

Sesen’s quality assurance framework is built on a multi-layered process designed to eliminate risk, improve consistency, and meet the highest standards of regulatory and clinical accuracy. Our system combines qualified linguists, rigorous review steps, and cutting-edge QA technologies to deliver publication-ready content for life sciences applications.

Every project begins with the selection of highly qualified linguists. All translators and reviewers are native speakers of the target language and possess subject matter expertise in the relevant life sciences domain. We verify credentials through a structured onboarding process that includes reference checks, test translations, and ongoing performance evaluations.

Sesen follows a robust TEP process that includes Translation, Editing, and Proofreading, with a final QA review. Each role is performed by a separate linguist to ensure objective assessment at every stage. This independent review structure allows for multiple checkpoints that catch errors, refine style, and confirm terminology consistency.

Our QA process combines human linguistic expertise with automated tools to deliver precision at scale. We use industry-standard tools such as Xbench, Verifika, and Trados QA Checker to perform checks on tags, numbers, formatting, repeated segments, and terminology consistency. Human reviewers then perform contextual checks to capture nuance, tone, and formatting integrity that automated tools may miss.

Consistent terminology is critical for regulatory submissions, product labeling, and patient-facing content. Sesen integrates client-approved glossaries and terminology databases into all projects and ensures alignment with style guides, including region-specific writing preferences and regulatory requirements. We also support terminology harmonization across multiple product lines and markets.

Before final delivery, every file undergoes a final linguistic QA to ensure accuracy, completeness, and formatting integrity. For select content types, we offer optional in-country review or back-validation by local clinical or regulatory stakeholders. This step ensures cultural and scientific accuracy and is particularly important for informed consent forms, patient materials, and market-facing content.

Advanced QA Tools Backed by Human Expertise

At Sesen, we combine the precision of technology with the insight of expert linguists to deliver consistent and regulator-ready translations. Our technology stack is designed to enhance quality, streamline workflows, and ensure full auditability for global life sciences content.

We leverage industry-standard QA tools to automatically detect and flag potential issues across large volumes of content. Automated checks include tag validation, formatting consistency, missing numbers or units, repeated segments, and glossary adherence. These tools help accelerate turnaround times while reducing manual errors.

SesenGPT is our proprietary AI engine trained exclusively on life sciences data. It supports context-aware pre-QA by identifying linguistic anomalies, inconsistencies, and tone mismatches that generic QA tools may overlook. This advanced layer of AI-driven review strengthens the reliability and clinical relevance of translated content.

We work within client-preferred translation environments and support leading computer-assisted translation (CAT) tools including Trados Studio, memoQ, Phrase, and Wordfast. Our QA checks are fully integrated into these tools to maintain translation memory consistency, terminology accuracy, and formatting fidelity.

Our workflows include structured version control and change tracking to maintain full traceability. Every edit and reviewer comment is logged, time-stamped, and accessible for audit purposes. This is critical for regulatory documentation, clinical study materials, and any content that may be reviewed by authorities or ethics committees.

Compliance With ISO and Industry Benchmarks

Sesen’s quality assurance process is fully aligned with international standards that govern life sciences translation, regulatory compliance, and medical content integrity. Our structured approach ensures that every project meets or exceeds the expectations of global regulatory authorities and client-specific quality systems.

We operate under three core ISO certifications that provide the foundation for consistent and reliable language services:

  • ISO 17100
    Specifies requirements for the core processes, resources, and quality assurance involved in professional translation services. Ensures translator qualifications, traceable workflows, and independent linguistic review.
  • ISO 9001
    Defines the criteria for a robust quality management system. Supports continuous improvement, client satisfaction, and risk-based thinking across all departments and workflows.
  • ISO 13485
    Applies specifically to medical device quality systems. Ensures compliance with regulatory requirements for safety, efficacy, and documentation in the medical device sector.

Sesen integrates quality protocols that align with region-specific regulations and global standards, including:

  • GxP: Good Practice guidelines for pharmaceuticals, clinical trials, and manufacturing
  • GDPR: Data protection and confidentiality for patient-facing materials and clinical records
  • EMA, FDA, PMDA, NMPA: Regional health authority expectations for labeling, submissions, and safety documentation

We regularly update our processes to reflect changes in regulatory guidance and linguistic quality standards across global markets.

In addition to external certifications, Sesen maintains a comprehensive library of internal Standard Operating Procedures (SOPs) that guide every phase of our translation and QA workflows. These documents support consistency, traceability, and compliance for both internal teams and external audits.

In-Country Review & Back-Validation

In-country review and back-validation are powerful quality assurance steps that provide localized validation for critical life sciences content. While optional, these reviews are highly recommended for clinical, regulatory, and patient-facing materials where precision, cultural relevance, and regulatory alignment are essential.

Sesen partners with professional native linguists, local clinicians, and client-affiliated experts to conduct targeted reviews that verify translation accuracy in real-world context. These reviewers validate the content against country-specific terminology, clinical conventions, and regulatory expectations.

Our team manages the entire process, from reviewer selection and training to comment tracking and implementation. Reviewers are briefed with style guides, product references, and clinical background to ensure consistent and informed feedback.

All feedback is systematically reviewed by our internal QA leads and implemented in alignment with project goals and regulatory compliance. This final step is fully integrated into our quality workflow, supporting complete lifecycle validation and audit readiness.

Whether for informed consent forms, product labeling, or clinical protocols, in-country review helps ensure the content resonates with target users, regulators, and local stakeholders.


Learn more about our In-Country Review process ›

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Keeping Pace With the Evolving Standards of Quality

The expectations for quality in life sciences translation are shifting rapidly as new technologies, regulatory models, and patient engagement tools emerge. Sesen continuously evolves its QA practices to meet these changes and to support clients in staying ahead of compliance and innovation trends.

Artificial intelligence is playing a growing role in translation quality control. While machine learning can accelerate QA by detecting terminology mismatches, formatting issues, and anomalies in tone or structure, human oversight remains essential. SesenGPT, our proprietary life sciences AI engine, is used to augment—not replace—expert linguistic review for greater accuracy and contextual relevance.

With the rise of digital health platforms, patient portals, and remote monitoring, multilingual QA has become critical. Sesen performs specialized review of digital content to ensure that translations are clear, culturally appropriate, and accessible to diverse patient populations across regions and languages.

Electronic Clinical Outcome Assessments (eCOA), eConsent forms, and device UIs require precise and user-friendly translations. Sesen provides targeted linguistic QA for digital interfaces to ensure readability, consistency, and usability in clinical trial settings. We apply specialized UI string review methods to validate content in context.

RWE studies often involve data from multiple sources, including EMRs, patient surveys, and observational reports. The unstructured nature of this content poses unique QA challenges. Sesen applies structured review methods to ensure linguistic accuracy, regulatory suitability, and terminological consistency across diverse document types.

Global regulatory authorities are increasingly encouraging modular submissions to streamline document management. Sesen supports quality assurance for modular content reuse, including common technical documents (CTD), drug labels, and IVDR-compliant files. Our QA workflows are designed to maintain consistency across components while adapting localized elements as needed.

Proven Quality, Proven Results

Global life sciences companies choose Sesen because we consistently deliver high-quality translations that meet the demands of regulatory compliance, clinical accuracy, and market readiness. Our commitment to quality assurance is not just a process. It is a proven advantage for pharmaceutical, biotech, medical device, and CRO partners operating across international markets.

Sesen supports some of the world’s leading pharmaceutical companies, clinical research organizations, and medical device manufacturers with regulatory-grade translations. Whether preparing product labeling for submission or translating investigator brochures for global trials, clients rely on our accuracy, consistency, and deep subject matter expertise.

Our quality-driven approach has helped clients reduce regulatory rejections, minimize back-and-forth with health authorities, and accelerate market access timelines. From CTD and eCTD modules to patient-facing materials, our quality assurance systems contribute directly to faster approvals and fewer compliance risks.

Many of our clients return to Sesen for long-term partnerships after experiencing the reliability of our translation and QA workflows. Our high repeat engagement rate is a testament to the trust we build through transparent communication, measurable quality metrics, and consistent delivery.

Frequently Asked Questions

Quality Assurance (QA) refers to the overall process and system designed to prevent errors during translation, including defined workflows, tool integration, and multi-step review. Quality Control (QC) is the inspection of translated content to detect and correct errors after the work is completed. At Sesen, both QA and QC are part of a continuous quality management system aligned with ISO 9001 and ISO 17100.

Yes. Sesen offers in-country review and back-validation for clinical, regulatory, and patient-facing content. These reviews are conducted by qualified local professionals to ensure medical accuracy, cultural relevance, and regulatory alignment in the target country. This step is optional but strongly recommended for high-impact content such as informed consent forms and product labeling.

Client feedback is logged, tracked, and integrated through a structured change management process. All changes are version controlled and reviewed by senior linguists to ensure consistency with project goals, terminology, and style guidelines. If applicable, feedback is used to update glossaries and improve future deliveries.

Sesen supports a wide range of file formats compatible with industry-standard QA tools and CAT platforms, including:

  • Microsoft Word, Excel, PowerPoint
  • PDF (OCR-enabled)
  • XML, HTML, XLIFF
  • InDesign (IDML)
  • JSON, CSV, and software string files

We ensure all formatting, tags, and layout elements remain intact throughout the QA process.

SesenGPT is a proprietary AI engine developed by Sesen and trained exclusively on life sciences content, medical terminology, and regulatory documentation. It is used to assist in pre-QA review by identifying contextual inconsistencies, terminology mismatches, and formatting anomalies. Unlike general-purpose AI tools, SesenGPT provides domain-specific accuracy that enhances but does not replace human review.

Related Services Supporting Translation Quality

Quality assurance at Sesen is not limited to a single step. It is embedded across our full spectrum of life sciences translation and localization services. Explore how our specialized solutions ensure accuracy, consistency, and compliance at every stage of your global content workflow.

Explore Our Related Services:

  • In-Country Review

    Native subject matter experts validate translations for regulatory, clinical, and patient-facing content in the local context.

  • Regulatory Submission Translation

    High-accuracy translations of CTD, eCTD, and regional submission documents for EMA, FDA, PMDA, NMPA, and more.

  • Regulatory Labeling Translation

    Certified translation of SmPCs, IFUs, packaging components, and drug labels aligned with global labeling regulations.

  • Medical Writing Translation

    Expert handling of protocols, investigator brochures, clinical study reports, and other regulatory writing content.

  • CTD and eCTD Translation

    Specialized translation for Module 1–5 content with formatting support for eCTD publishing platforms.

  • IFU Translation

    ISO 13485-compliant translations of Instructions for Use (IFUs) across devices and global markets.

  • Label Review and In-Context QA

    Visual validation of translated content directly in labeling layouts and regulatory submission files.

Ready to Build Quality Into Your Global Content Strategy?

Whether you need high-impact translations for regulatory submissions, medical device labeling, or multilingual patient engagement, Sesen brings the quality assurance life sciences companies trust. Our expert teams, validated workflows, and certified systems ensure your content is accurate, compliant, and globally aligned from day one.

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