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Biotechnology Translation: Precision for a Regulated Industry

Biotechnology translation is a specialized discipline that ensures scientific accuracy, regulatory compliance, and global accessibility for biotech innovations. As companies expand internationally, precise translations are critical for regulatory approvals, intellectual property protection, and effective communication of complex scientific data.

However, translating biotechnology content comes with unique challenges—this is where Sesen excels. Our expert translations meet the highest industry standards by ensuring:

  • Regulatory Compliance – Adherence to FDA, EMA, PMDA, CFDA, and other global regulations.
  • Scientific Accuracy – Consistency in biotech terminology across research, clinical trials, and manufacturing.
  • Technical Clarity – Seamless localization of intricate biotech concepts for diverse audiences.

Even minor translation errors can cause approval delays, safety risks, and market entry barriers. With Sesen’s expert biotechnology translation services, your documents remain precise, compliant, and globally effective, empowering biotech innovations worldwide.

Specialized Expertise

Biotechnology translation demands more than linguistic proficiency—it requires deep scientific expertise and regulatory knowledge to ensure accuracy, compliance, and clarity. Given the highly technical nature of biotech content, even minor translation errors can lead to regulatory delays, safety risks, and intellectual property disputes.

This is why you need a specialized life sciences translation provider like Sesen to ensure precise, compliant, and high-quality translations.

Why General Translators Are Not Sufficient for Biotechnology:

Biotech documents contain specialized terminology, industry-specific nomenclature, and evolving scientific concepts. Sesen’s linguists are subject matter experts (SMEs) in molecular biology, biopharmaceuticals, and genetic engineering, ensuring precise and contextually accurate translations.

Compliance with FDA (U.S.), EMA (Europe), PMDA (Japan), CFDA (China), and other global agencies is critical. Regulatory submissions, clinical trial documentation, and manufacturing protocols must be translated with absolute precision to avoid delays, rejections, or non-compliance risks.

Errors in clinical trial protocols, informed consent forms (ICFs), and pharmacovigilance reports can compromise patient safety and trial integrity. Sesen ensures compliance with Good Clinical Practice (GCP) guidelines and conducts linguistic validation and back translation to maintain accuracy.

Biotech patents, research papers, and licensing agreements require precise translation to protect intellectual property rights across multiple jurisdictions. Inaccuracies can lead to legal disputes, patent invalidation, or loss of market exclusivity.

With Sesen’s specialized biotechnology translation solutions, companies benefit from compliance-ready, scientifically accurate translations that enable faster regulatory approvals, seamless global market access, and strong IP protection—ensuring biotech innovations reach the world with confidence.

Comprehensive Biotechnology Translation Services

Sesen provides highly specialized biotechnology translation services, ensuring scientific accuracy, regulatory compliance, and market readiness. Our expert linguists and subject matter specialists provide precise, industry-specific translations across all biotech disciplines, from regulatory submissions to software localization.

Ensuring biotech companies meet strict global regulatory standards, our translations support:

  • Regulatory submissions for FDA (U.S.), EMA (Europe), PMDA (Japan), CFDA (China), and other agencies.
  • Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) filings.
  • CMC (Chemistry, Manufacturing, and Controls) documentation, safety reports, and risk assessments.

Learn more about our Regulatory Translation Services

Clinical trial success depends on accurate, regulation-compliant documentation for sponsors, investigators, and patients. We provide:

  • Clinical trial protocols, investigator brochures, and informed consent forms (ICFs) aligned with Good Clinical Practice (GCP).
  • Patient-reported outcomes (PROs), case report forms (CRFs), and adverse event reports.
  • Pharmacovigilance translations, ensuring safety reporting and compliance with regulatory authorities.

Explore our Clinical Trial Translation Services

Protecting biotech innovations requires precise, legally sound translations to support global IP filings. Our expertise covers:

  • Biotechnology patents, patent applications, and licensing agreements.
  • IP protection documents, ensuring legal clarity across jurisdictions.
  • Technical specifications and research findings for patent filings and regulatory submissions.

Learn more about our Patent & Intellectual Property Translations

Biotech manufacturing demands strict compliance with global regulatory frameworks. Our translations ensure:

  • Standard Operating Procedures (SOPs) for biopharmaceutical production.
  • Good Manufacturing Practices (GMP) documentation, aligning with ISO 13485:2016.
  • Quality control reports, batch records, and process validation documents.

Explore our Manufacturing & Process Documentation Services

Biotech firms must communicate complex scientific concepts effectively to global audiences. We translate:

  • Product packaging, labeling, and Instructions for Use (IFUs) for medical and biotech devices.
  • Scientific publications, journal articles, and conference presentations.
  • Marketing collateral, website content, and multimedia materials for biotech outreach.

Learn more about our Marketing & Product Information Translations

The biotech industry relies on software-driven solutions to streamline research, diagnostics, and compliance. Our localization services cover:

  • Laboratory Information Management Systems (LIMS) for global deployment.
  • Localization of biotech diagnostic and research software UI for multilingual users.
  • Translation of electronic health records (EHRs) and biotech analytics platforms.

Explore our Biotech Software Localization Services

Quality Assurance & Compliance

At Sesen, quality and regulatory compliance are at the core of our biotechnology translation services. We implement rigorous quality control measures, ensuring translations meet industry-specific regulatory, scientific, and linguistic standards.

Sesen adheres to international quality standards, ensuring accuracy, consistency, and regulatory compliance across all biotech translations:

  • ISO 17100 – Certified translation processes for high-quality, professional translations.
  • ISO 9001:2015 – Quality management system ensuring continuous improvement and operational excellence.
  • ISO 13485:2016 – Compliance with medical device and life sciences regulatory requirements.

Accuracy in biotechnology translations is mission-critical. Our linguistic validation and back translation processes safeguard against misinterpretations and inconsistencies:

  • Linguistic validation – Ensures terminology precision, readability, and cultural adaptability for clinical trials, regulatory submissions, and patient-facing materials.
  • Back translation & reconciliation – Critical for pharmacovigilance, clinical documentation, and high-risk biotech content, ensuring accuracy by retranslating text back into the source language for comparison.

Biotechnology translations require expert knowledge of molecular biology, bioengineering, and regulatory science. Sesen’s SME-led translation teams ensure:

  • Technical accuracy in highly specialized biotech, pharmaceutical, and clinical research content.
  • Regulatory alignment with global biotech authorities, ensuring documentation meets FDA, EMA, PMDA, and CFDA requirements.
  • Context-driven precision, eliminating linguistic ambiguities that could impact compliance or patient safety.

With Sesen’s quality-driven biotech translation approach, companies gain scientifically precise, regulation-compliant translations—critical for securing approvals, protecting intellectual property, and ensuring market success.

Technology-Enabled Human Translation

At Sesen, we combine cutting-edge translation technologies with expert linguists to deliver precise, regulation-compliant biotech translations at scale. Our human-centric, technology-driven approach ensures scientific accuracy while optimizing efficiency, consistency, and security for global biotech companies.

Sesen leverages AI-driven workflow optimization while maintaining human quality control by specialized biotech linguists. Our approach integrates:

  • AI-Powered Workflow Automation – Streamlining project management, content analysis, and terminology extraction to enhance productivity while ensuring scientific and regulatory accuracy.
  • Context-Aware Quality Assurance (QA) Tools – Automatically detecting terminology inconsistencies, formatting errors, and regulatory non-compliance risks to improve translation precision.
  • Real-Time Collaboration Platforms – Enabling seamless coordination between linguists, subject matter experts, and regulatory reviewers for faster, more reliable biotech translations.

By combining AI-enabled efficiencies with expert human oversight, Sesen delivers accurate, compliance-driven biotech translations—ensuring faster turnaround times, unmatched consistency, and global regulatory readiness.

Consistency is critical in biotech translations. Sesen utilizes:

  • Translation Memory (TM) – Storing approved biotech-specific translations to enhance consistency, reduce costs, and accelerate turnaround times for regulatory submissions and clinical documentation.
  • Terminology Management Systems – Custom biotech glossaries and termbases, ensuring precise scientific, medical, and legal terminology across all languages.
  • Dynamic Content Adaptation – Ensuring updates in drug labeling, clinical trial data, and regulatory documents are accurately reflected across all translated materials.

Biotech translations involve highly sensitive data, from clinical trial results to proprietary research. Sesen enforces strict security protocols to protect intellectual property, patient information, and regulatory data:

  • HIPAA & GDPR Compliance – Ensuring full data privacy in biotech, pharmaceutical, and clinical documentation.
  • End-to-End Encryption & Secure File Handling – Protecting biotech research, patents, and clinical trial data.
  • AI-Powered Risk Detection – Identifying data exposure risks in machine-assisted translation workflows.

With Sesen’s technology-enabled human translation solutions, biotech firms benefit from unparalleled accuracy, regulatory compliance, and data security, ensuring faster approvals, seamless global expansion, and uncompromised scientific integrity.

Types of Biotech Documents We Translate

Sesen provides high-precision translations for a wide range of biotechnology documents, ensuring regulatory compliance, scientific accuracy, and seamless global communication across R&D, clinical, and commercial biotech operations. Our expertise covers:

  • Investigational New Drug (IND) applications
  • New Drug Application (NDA) filings
  • Biologics License Application (BLA) filings
  • Chemistry, Manufacturing, and Controls (CMC) documentation
  • Good Manufacturing Practices (GMP) guidelines
  • Standard Operating Procedures (SOPs)
  • Pharmacovigilance reports
  • Risk management plans
  • Clinical trial agreements
  • Ethics committee submissions
  • Clinical trial protocols
  • Investigator brochures
  • Study reports
  • Case Report Forms (CRFs)
  • Patient-Reported Outcomes (PROs)
  • Informed Consent Forms (ICFs)
  • Patient recruitment materials
  • Scientific research papers
  • Biotechnology journal articles
  • Genetic sequencing reports
  • Bioinformatics documentation
  • Biotechnology patents
  • Patent applications
  • Licensing agreements
  • Technology transfer documents
  • Confidentiality agreements (NDAs)
  • Research and development (R&D) reports
  • Bioprocessing procedures
  • Drug labeling
  • Packaging inserts
  • Safety data sheets (SDS)
  • Toxicology reports
  • Batch manufacturing records
  • Quality control reports
  • Biotechnology product brochures
  • White papers
  • Website content
  • Press releases
  • Investor presentations
  • Educational materials for biotech professionals
  • Training materials
  • Scientific conference materials
  • Keynote presentations
  • Laboratory Information Management Systems (LIMS)
  • Biotech research software localization
  • Diagnostics UI translations
  • Electronic Health Records (EHR)
  • Clinical data platforms

Why Choose Sesen?

Sesen is a trusted partner for biotechnology companies, delivering high-precision, regulation-compliant translations that facilitate global expansion, regulatory approvals, and market success. Here’s what sets us apart:

Biotechnology translations demand scientific precision to avoid regulatory setbacks, legal risks, and market-entry barriers. Sesen ensures:

  • Subject matter expert (SME) linguists with backgrounds in molecular biology, pharmaceuticals, and bioengineering.
  • Stringent multi-step quality control, including linguistic validation, back translation, and expert review.
  • Custom biotech glossaries and terminology management, maintaining consistency across all documentation.

In the fast-paced biotech sector, speed is essential. Sesen optimizes translation workflows through:

  • AI-powered workflow automation to accelerate project timelines without compromising quality.
  • Real-time collaboration platforms, allowing seamless interaction between linguists, regulatory specialists, and project managers.
  • Dedicated project teams for urgent regulatory submissions, clinical trials, and product launches.

Biotech translations must align with strict global regulatory requirements to ensure product approvals and market access. Sesen delivers:

  • Expertise in FDA (U.S.), EMA (Europe), PMDA (Japan), and CFDA (China) regulations.
  • ISO 13485:2016-certified processes for medical and biotech device translations.
  • Regulatory translation accuracy for clinical trials, IND/NDA submissions, and pharmacovigilance reports.

Unlike general translation providers, Sesen employs linguists with in-depth biotechnology expertise, ensuring:

  • Fluency in biotech-specific terminology, covering everything from CRISPR technology to biologics manufacturing.
  • Experience in translating for clinical trials, regulatory filings, and IP protection.
  • Localized translations that maintain scientific accuracy while adapting to regulatory and cultural nuances.

Partner with Sesen for Precision-Driven Biotechnology Translations

Ensure regulatory compliance, scientific accuracy, and seamless global communication with Sesen’s expert biotechnology translation services. Whether you need regulatory filings, clinical trial documentation, or IP protection translations, our specialized linguists and industry-leading processes deliver accuracy, efficiency, and compliance at every stage.

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