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regulatory-labeling-qa

Accurate, Compliant Labeling Starts with Expert QA

Regulatory authorities across the globe expect translated product labels to be linguistically precise, visually accurate, and fully aligned with regional requirements. At Sesen, our Regulatory Labeling QA services are purpose-built for life sciences companies navigating multilingual submissions. We work with pharmaceutical, biotechnology, medical device, and diagnostics organizations to ensure every translated label is free of errors, properly formatted, and ready for market clearance. Our in-context QA process includes layout validation, terminology verification, and region-specific compliance checks to reduce regulatory risk and accelerate product approvals.

Why Regulatory Labeling QA Matters

Accurate product labeling is critical for ensuring patient safety and achieving regulatory approval in global markets. For life sciences companies, even minor errors in translated labels can lead to significant consequences, including submission rejections, compliance violations, and product recalls. Regulatory authorities such as the EMA, FDA, PMDA, NMPA, and ANVISA closely scrutinize label content for accuracy, consistency, and region-specific formatting.

Implementing a robust labeling QA process helps:

  • Prevent costly relabeling, reprinting, and distribution delays
  • Maintain consistent terminology aligned with regulatory expectations
  • Preserve layout fidelity across languages, avoiding truncation and formatting issues
  • Minimize the risk of safety-related errors caused by mistranslation or mislabeling

Common Consequences of Inadequate Labeling QA

  • Regulatory rejection due to non-compliant formatting or terminology
  • Delays in product launches across key markets
  • Violations of MDR, IVDR, or other region-specific regulations
  • Patient harm due to incorrect dosing instructions, contraindications, or safety symbols

A comprehensive QA process is essential for ensuring translated labels are not only linguistically accurate but also technically correct and submission-ready. Sesen’s specialized QA services are designed to catch these issues early, supporting faster approvals and reducing risk across multilingual regulatory workflows.

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Our Comprehensive Labeling QA Workflow

Sesen’s regulatory labeling QA process is engineered to support the unique challenges of multilingual submissions in the life sciences industry. Our workflow integrates linguistic precision, technical validation, and regulatory expertise to deliver submission-ready labels across 150+ languages and global markets.

We perform quality checks directly on final label layouts, including PDFs, packaging files, and Instructions for Use (IFU) mockups. Native-language reviewers evaluate grammar, clarity, and fluency while considering layout constraints, ensuring the translated text is accurate and contextually appropriate for the target audience.

We validate the use of approved terminology by cross-referencing client-provided glossaries, internal style guides, and regulatory dictionaries such as MedDRA, EDQM, and WHO-DD. This step ensures consistent usage of technical terms, abbreviations, and regulatory language across all files and target languages.

Our QA team verifies that all translated text fits within the designated layout without misalignment, clipping, or font rendering issues. Special attention is given to language-specific expansion, particularly in scripts like Chinese, Arabic, Russian, and German, which often impact formatting and design integrity.

We inspect all machine-readable elements and safety symbols for accuracy and compliance. This includes verifying GS1 barcode structure, UDI formatting, and correct usage of symbols required by standards such as ISO 15223-1, IEC 60601, and IEC 62366. We ensure consistency between digital assets and printed output.

Our QA team validates each label’s compliance with national and international regulatory requirements. We tailor reviews based on the target market’s guidelines, including formatting, language mandates, and labeling structure. Regions covered include:

  • EU MDR and IVDR
  • U.S. FDA
  • Health Canada
  • PMDA (Japan)
  • TGA (Australia)
  • NMPA (China)
  • ANVISA (Brazil)

This regional alignment step ensures your labels meet country-specific expectations for format, language, and content structure, reducing the risk of regulatory rejections or launch delays.

Who Needs Regulatory Labeling QA?

Sesen’s Regulatory Labeling QA services are purpose-built for life sciences organizations preparing multilingual submissions for global markets. Whether labels are created in-house or through third-party vendors, thorough quality assurance is essential to meet regional compliance standards and avoid regulatory setbacks.

Our QA solutions support:

Ensure accurate and compliant drug labeling for commercial products, clinical trial materials, and secondary packaging across all target countries.

Validate complex, multi-component labels for biologics, gene therapies, and cell-based treatments where precision and regulatory alignment are critical.

Comply with EU MDR, IVDR, and FDA requirements for Instructions for Use (IFUs), device packaging, and UDI labeling in all supported languages.

Guarantee submission-ready label content for investigational products, patient materials, and region-specific regulatory documentation.

Minimize review cycles by integrating expert QA before submission, ensuring language accuracy, layout integrity, and regulatory compliance.

Partner with Sesen to add a layer of QA validation to final label files, ensuring end-client satisfaction and reduced risk of post-print corrections.

Our services are designed to seamlessly fit into both internal and outsourced labeling workflows, supporting faster approvals and consistent global product launches.

How It Works with Sesen

Sesen offers flexible regulatory labeling QA solutions to support both new and existing workflows, whether you need standalone quality review or full-service translation and compliance support. Our QA services are scalable and designed to reduce risk, improve accuracy, and accelerate time to submission.

We perform detailed quality assurance on client-supplied translated and formatted labels, regardless of which language service provider originally completed the work. This includes in-layout linguistic checks, formatting validation, and regulatory alignment to ensure the final assets are error-free and submission-ready.

For clients using Sesen for both translation and QA, we embed quality assurance throughout the multilingual labeling process. This integrated model streamlines project management, reduces handoff errors, and delivers greater consistency across language versions and label components.

To support large-scale or recurring submissions, we offer QA integration with label reuse and automation modules. This allows for efficient validation of reused content, reduced duplication of effort, and consistent quality across multiple product lines, SKUs, or regulatory updates.

Whether you are preparing labels for new product launches, label updates, or regulatory resubmissions, Sesen’s QA solutions are designed to fit seamlessly into your compliance process and labeling ecosystem.

Related Services

Sesen provides end-to-end language solutions to support every stage of your global labeling and regulatory submission process. Our integrated services are designed to enhance consistency, accuracy, and compliance across all markets and product lines.

Multilingual translation of regulatory labels, packaging, and supporting materials with full adherence to country-specific requirements and industry terminology.

High-accuracy translations of drug labels, cartons, leaflets, and blister packaging content in compliance with FDA, EMA, and other international health authorities.

Specialized translation services for medical device labeling, including safety symbols, technical descriptions, and language requirements under MDR and IVDR.

Professional translation of Instructions for Use (IFUs) for devices and diagnostics, ensuring clarity, usability, and regional language compliance.

To learn more about how these services work together to support faster, error-free submissions, explore the individual pages linked above or contact us directly.

FAQs: Regulatory Labeling QA

Regulatory Labeling QA is a specialized quality review process that ensures translated product labels meet all linguistic, formatting, and regulatory standards required by global health authorities. It is performed on final layouts and is essential for achieving submission-ready compliance across multilingual markets.

Standard translation QA focuses on language accuracy and consistency in text files. Regulatory labeling QA goes further by validating the content within formatted label files, including layout verification, symbol and barcode accuracy, truncation checks, and compliance with regional regulatory formats such as EU MDR, IVDR, and FDA guidelines.

Yes. Sesen provides standalone QA services for labels translated or formatted by other language service providers. We perform independent validation to identify errors, ensure regulatory compliance, and reduce the risk of submission delays or relabeling.

Turnaround time varies based on the number of languages, file types, and complexity of the layout. Most QA projects are completed within 3 to 7 business days. For urgent submissions, expedited options may be available upon request.

Yes. Our QA services cover a range of regulated content, including Instructions for Use (IFUs), patient inserts, medication guides, and multilingual leaflets. We review these files in layout to ensure compliance with both language and formatting requirements.

We offer regulatory labeling QA aligned with the requirements of major health authorities, including the EMA, FDA, PMDA, NMPA, Health Canada, TGA, and ANVISA. Our team ensures each label meets the applicable regional standards for structure, content, and formatting.

Need Submission-Ready Label QA Services?

Work with Sesen to ensure your translated product labels meet global regulatory standards. Our expert QA process validates language accuracy, layout integrity, and compliance across 150+ languages for faster, risk-free approvals.

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