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Label Review & In-Context QA
— In-layout linguistic quality assurance for regulated content.
Ensure linguistic accuracy, formatting integrity, and regulatory compliance across multilingual labels, IFUs, and packaging. Our expert reviewers validate translations directly in final layouts—catching errors standard checks miss to safeguard patient safety and meet global submission standards.
In-Context QA for Regulated Labeling Accuracy
Label Review & In-Context QA is a critical step in the life sciences localization workflow, ensuring translated content is not only linguistically accurate but also contextually correct within the final layout. By reviewing content directly in formatted packaging, labels, and IFUs, Sesen helps life sciences companies avoid costly errors, improve submission quality, and safeguard patient safety.
This process is essential for pharmaceutical, medical device, and biotechnology organizations that must comply with stringent labeling requirements across global markets. Our in-layout QA checks detect issues such as truncated text, misaligned translations, regulatory non-compliance, and formatting inconsistencies that are often missed in standard linguistic review.
Sesen’s Label Review & In-Context QA services support compliance with international regulatory standards, including those of the FDA, EMA, MHRA, PMDA, and CFDA. We provide scalable, audit-ready QA solutions for multilingual labeling and packaging across 150+ languages, helping clients launch products confidently and compliantly worldwide.
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What is In-Context Linguistic QA?
In-Context Linguistic QA is a specialized quality assurance process that evaluates translated content within the final layout or design format—such as packaging, Instructions for Use (IFUs), and product labeling—rather than as standalone text. This final-stage review ensures that translated content is accurately rendered, properly placed, and fully compliant with formatting and regulatory requirements before print or submission.
Unlike standard linguistic QA, which reviews translations in isolated formats (e.g., bilingual spreadsheets), in-context QA focuses on how content appears within the actual production files. It identifies layout-specific issues such as text truncation, formatting errors, incorrect line breaks, font mismatches, and bi-directional text misrendering—critical risks for regulated life sciences content.
Sesen performs in-layout reviews using industry-standard tools including Adobe InDesign, PDF editors, Articulate, FrameMaker, and XML-based labeling systems. Our team uses both visual and checklist-driven validation to ensure consistency between the source and target content, correct use of approved terminology, and alignment with regulatory submission-ready artwork. This step is essential for ensuring global labeling accuracy and audit-readiness.
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Label Review for Global Regulatory Compliance
Accurate and compliant labeling is essential for life sciences companies operating across international markets. Sesen’s Label Review & In-Context QA service ensures that translated content is not only linguistically precise, but also adheres to country-specific regulatory requirements and product safety standards.
Our expert reviewers validate each label against the source content and applicable regulatory reference texts, ensuring complete and accurate translation of critical product information, including dosage instructions, contraindications, safety warnings, legal disclaimers, and mandatory labeling elements. We verify the correct use of approved terminology and perform cross-language consistency checks across SKUs, batches, and therapeutic areas.
In addition, we assess readability and clarity, confirming that all localized content remains accessible and unambiguous to end users and healthcare professionals. We also ensure compliance with local formatting regulations, such as font size requirements, unit conventions, and mandatory phrasing based on regulatory authority guidelines (e.g., FDA, EMA, PMDA, Health Canada, ANVISA).
By combining linguistic expertise with regulatory knowledge, Sesen helps clients meet the stringent demands of multilingual product labeling, minimize risk of rejection during health authority reviews, and maintain patient safety across global markets.
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In-Layout Quality Checks for Packaging and IFUs
Effective in-layout quality assurance is essential for ensuring that translated content on packaging, Instructions for Use (IFUs), and product labels is not only accurate but visually correct within the final formatted files. Sesen performs comprehensive in-layout reviews to catch formatting, design, and rendering issues that can compromise readability or regulatory compliance.
Our QA experts perform visual context verification across all final file types—examining layout integrity, text alignment, spacing, and label hierarchies to ensure content appears exactly as intended. We validate font styles, ensure special characters and diacritics render correctly, and flag any truncation, overflow, or misaligned text that could distort meaning or violate packaging regulations.
Special attention is given to bi-directional and right-to-left (RTL) languages such as Arabic and Hebrew, where improper rendering, mirroring, or punctuation placement can result in serious regulatory and safety issues. We also identify broken lines, cut-off warnings, and any missing or displaced content in space-constrained label layouts.
Sesen’s in-layout QA integrates seamlessly with design files in Adobe InDesign, PDF, and XML-based artwork systems, ensuring end-to-end validation from translation through to final packaging approval.
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Technology-Driven QA Workflow for Life Sciences Labeling
Sesen’s Label Review & In-Context QA is powered by a technology-enabled workflow designed to deliver precision, speed, and compliance across complex multilingual labeling projects. Our process integrates seamlessly with industry-standard tools and regulatory content management systems to ensure consistency and traceability throughout every stage of production.
We work directly within Adobe InDesign, FrameMaker, and XML-based layout systems, enabling real-time in-context validation of final packaging, IFUs, and regulatory labels. Our team supports collaborative artwork review platforms, leveraging advanced PDF annotation tools and version-controlled environments to efficiently flag and track layout or linguistic issues.
Our QA workflow is fully integrated with translation, desktop publishing (DTP), and regulatory teams to eliminate communication silos and reduce turnaround times. Every project is guided by structured checklists, terminology glossaries, and validation logs that ensure full transparency and audit-readiness.
This robust, technology-driven approach helps life sciences organizations maintain high standards for labeling accuracy, regulatory compliance, and global consistency, while accelerating time to market.
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Common Labeling QA Issues We Resolve
In life sciences, even small errors in packaging or labeling can lead to regulatory non-compliance, product recalls, or patient safety risks. Sesen’s in-context QA process is designed to identify and resolve high-impact issues that standard linguistic checks often miss.
We detect mismatches between translated content and approved label artwork, ensuring full alignment between source and target files across all layout versions. Our reviewers validate dosage accuracy and unit conversions—a critical step in preventing misadministration of pharmaceuticals or medical devices in global markets.
Our in-layout checks also catch overlapping, cut-off, or hidden text, particularly in space-constrained label designs or small packaging formats. We verify that every element is clearly visible, properly formatted, and legible in the final print-ready files.
Additionally, we resolve label content discrepancies across SKUs, regions, and product lines, ensuring consistent terminology, branding, and regulatory phrasing across all localized assets. This consistency is vital for maintaining regulatory compliance and brand integrity across multilingual markets.
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Regulatory Alignment and Quality Assurance Compliance
Sesen’s Label Review & In-Context QA services are built on robust quality frameworks aligned with global life sciences regulations and industry best practices. Our QA processes fully comply with GxP, ISO 17100 for translation quality, and ISO 13485 for medical device quality management—ensuring that every labeling review meets the highest standards of accuracy, safety, and traceability.
We support pharmaceutical clients in meeting regulatory content structure requirements through alignment with Structured Product Labeling (SPL) and Identification of Medicinal Products (IDMP) standards. This ensures consistency in product information across submissions, countries, and systems.
All in-context reviews are backed by documented validation logs, checklists, and review trails, providing full transparency and audit readiness. Our processes support both internal QA documentation needs and third-party regulatory audits, helping clients reduce risk and maintain ongoing compliance across global product launches.
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Multilingual Labeling Support Across 150+ Languages
Sesen provides expert in-context QA for multilingual labeling, ensuring global product launches are both linguistically accurate and regulatory compliant. We support over 150 languages, leveraging a global network of professional native linguists with deep subject-matter expertise in pharmaceuticals, medical devices, and biotechnology.
Our process includes meticulous regional variation management—for example, distinguishing between Canadian French and EU French, or Brazilian Portuguese versus European Portuguese—ensuring labels meet both linguistic and market-specific regulatory requirements.
To support consistency across global SKUs, we apply terminology harmonization across product lines, therapeutic areas, and target markets. This ensures that approved terms, dosage expressions, and regulatory phrases are used uniformly across all languages and file formats, reducing risk and increasing brand and compliance integrity.
Sesen’s multilingual QA workflows are designed to streamline global labeling operations and help life sciences organizations scale safely into new markets with confidence.
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Why Life Sciences Leaders Choose Sesen
Sesen is a trusted partner for life sciences companies seeking high-precision label review and in-context linguistic QA services. Our work is grounded in deep domain expertise across pharmaceuticals, medical devices, biotechnology, and clinical research, enabling us to deliver quality solutions tailored to regulatory demands and market-specific challenges.
We have a proven track record supporting top-tier global life sciences companies, ensuring compliance with FDA, EMA, and other health authority standards across multilingual product labeling, packaging, and IFUs. Our team includes dedicated in-context QA specialists and professional native linguists, trained to identify layout-specific issues that standard reviews often overlook.
With agile, technology-enabled workflows, Sesen is uniquely positioned to deliver fast turnarounds, even for last-minute layout revisions, regulatory rechecks, or urgent submission deadlines—without compromising on accuracy or quality.
Partnering with Sesen means gaining a scalable, compliant, and responsive solution for global labeling success.
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