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Regulatory Translations for Life Sciences Compliance

Accurate regulatory translations are critical for global market access, patient safety, and regulatory approval. Mistranslations can result in delays, compliance failures, and legal risks, making precision essential for life sciences companies. Sesen delivers ISO 17100- and ISO 13485-certified translations, ensuring compliance with stringent global health authority standards, including the FDA (U.S.), EMA (EU), PMDA (Japan), CFDA (China), and Health Canada.

Our subject-matter experts translate clinical trial documents, regulatory submissions, product labeling, and pharmacovigilance reports with linguistic validation, back translation, and terminology management to meet industry best practices. Sesen’s secure technology infrastructure ensures confidentiality and regulatory compliance, supporting seamless approvals and market entry.

Sesen’s Expertise in Regulatory & Compliance Translations

Sesen specializes in high-precision regulatory translations for pharmaceutical, biotech, and medical device companies, ensuring compliance with global health authorities. Our expertise is built on industry best practices, regulatory knowledge, and ISO-certified quality processes.

  • Certified linguists with expertise in pharmaceutical, medical, and regulatory sciences.
  • In-depth knowledge of regulatory terminology and submission requirements across agencies such as the FDA, EMA, PMDA, CFDA, and Health Canada.
  • Expert handling of critical regulatory documents, including clinical trial submissions, Common Technical Documents (CTDs), and pharmacovigilance reports.
  • ISO 17100-certified translation processes ensuring accuracy, consistency, and audit readiness.
  • ISO 9001:2015-compliant quality management system, guaranteeing rigorous review and validation.
  • ISO 13485:2016 certification, meeting the highest standards for medical device regulatory translations.
  • Linguistic validation, back translation, and terminology management to ensure precision and compliance.
  • Extensive experience supporting regulatory approvals for pharmaceutical, biotech, and medical device manufacturers.
  • Seamless collaboration with regulatory affairs teams to ensure compliance with submission requirements.
  • Secure translation workflows that maintain confidentiality, integrity, and compliance with HIPAA, GDPR, and industry regulations.

With technical precision, regulatory expertise, and ISO-certified quality assurance, Sesen enables faster approvals, reduced compliance risks, and successful global market entry.

Regulatory Documents We Translate

Regulatory documentation in life sciences must be precisely translated to ensure compliance, patient safety, and approval by health authorities worldwide. Sesen provides ISO-certified translations of critical regulatory documents, supporting pharmaceutical, biotech, and medical device companies through every stage of development, from clinical trials to post-market surveillance.

  • Clinical Trial Protocols – Study objectives, methodology, and regulatory requirements for trial execution.
  • Investigator Brochures – Drug or device safety and efficacy data for clinical investigators.
  • Patient Consent Forms – Clear, patient-friendly documents explaining trial risks, benefits, and procedures.
  • Ethics Committee Submissions – Regulatory filings required for trial approval by institutional review boards (IRBs).
  • Common Technical Document (CTD) Submissions – Standardized regulatory dossiers for drug approval.
  • Summary of Product Characteristics (SmPCs) – Essential prescribing information, indications, and usage guidelines.
  • New Drug Applications (NDAs) & Marketing Authorization Applications (MAAs) – Formal submissions for drug approval.
  • Regulatory Compliance Correspondence – Communications with regulatory agencies regarding approvals, inspections, or compliance updates.
  • Patient-Reported Outcomes (PROs) – Questionnaires assessing patient experiences and treatment effectiveness.
  • Clinician-Reported Outcomes (ClinROs) – Assessments recorded by healthcare professionals.
  • Observer-Reported Outcomes (ObsROs) – Third-party evaluations of patient conditions.
  • Performance Outcomes (PerfOs) – Measured performance-based assessments (e.g., mobility tests, cognitive evaluations).
  • Adverse Event Reports – Detailed reports of unexpected side effects or reactions.
  • Risk Management Plans – Strategies for identifying and mitigating drug-related risks.
  • Drug Safety & Post-Market Surveillance Reports – Ongoing monitoring of drug safety and real-world performance.
  • Instructions for Use (IFUs) – Step-by-step user guides ensuring safe and effective device usage.
  • Device Labels & Packaging Inserts – Regulatory-compliant product labeling with safety and usage details.
  • Device Software Localization – Translation and adaptation of user interfaces, instructions, and regulatory documentation for medical software, ensuring compliance with FDA, MDR, and other global regulatory standards.
  • Manufacturing Process & Quality Control Reports – Documentation of production standards, batch testing, and quality assurance.

Sesen ensures that all regulatory translations maintain scientific accuracy, compliance alignment, and linguistic clarity, enabling faster approvals and seamless global market entry.

Global Compliance & Regulatory Translation Best Practices

Regulatory translation requires technical precision, consistency, and adherence to global standards to ensure compliance with FDA, EMA, PMDA, CFDA, and other health authorities. Sesen follows industry best practices to deliver accurate, audit-ready translations that support seamless regulatory approvals.

  • Ensures accuracy, cultural relevance, and regulatory compliance for patient-facing documents, such as Clinical Outcome Assessments (COAs) and Patient-Reported Outcomes (PROs).
  • Back translation and reconciliation detect inconsistencies to meet FDA and EMA requirements.
  • Standardized terminology databases ensure consistency across drug labeling, clinical trial documents, and IFUs.
  • Translation memory (TM) tools streamline updates for multi-region regulatory submissions, reducing costs and improving turnaround times.
  • Linguists with expertise in pharmaceutical, biotech, and medical device regulations review translations for compliance with ICH, GxP, MDR, and other industry frameworks.
  • SMEs ensure documents align with local regulatory terminology and submission expectations.
  • End-to-end encryption, secure translation platforms, and compliance with HIPAA & GDPR protect sensitive regulatory data.
  • Controlled access rights and audit trails ensure document integrity and traceability during submission processes.

By implementing industry-leading best practices, Sesen delivers high-precision regulatory translations that accelerate approvals, mitigate compliance risks, and enable global market access.

Technology-Enabled Human Translation

Regulatory translation demands scientific accuracy, linguistic precision, and compliance with global health authorities. Sesen integrates human expertise with advanced translation technology to enhance efficiency, consistency, and quality assurance while maintaining strict regulatory and data security standards.

  • Proprietary AI-driven terminology databases ensure consistent use of regulatory and scientific terms across clinical trial protocols, SmPCs, IFUs, and pharmacovigilance reports.
  • Automated terminology validation minimizes discrepancies, ensuring compliance with FDA, EMA, and ICH guidelines.
  • End-to-end encryption, controlled access, and audit logs safeguard sensitive regulatory documents.
  • Secure workflows comply with HIPAA, GDPR, and ISO 27001 for data protection in pharmaceutical and medical device submissions.
  • Advanced QA tools detect terminology inconsistencies, numerical mismatches, and formatting errors before submission.
  • Integrated linguistic validation and back translation workflows enhance accuracy in patient-facing documents, COAs, and informed consent forms.

Sesen’s technology-enabled human translation approach ensures compliant, high-precision regulatory translations, supporting faster approvals and seamless global market entry.

Why Choose Sesen for Regulatory Translation?

Regulatory translation requires technical precision, compliance expertise, and stringent quality control. Sesen is a trusted partner for pharmaceutical, biotech, and medical device companies, delivering ISO-certified translations that meet global regulatory standards.

  • Our team consists of pharma, biotech, and medical device experts with deep knowledge of regulatory terminology, clinical documentation, and compliance requirements.
  • We work with regulatory subject-matter experts (SMEs) to ensure translations align with FDA, EMA, PMDA, CFDA, and Health Canada standards.
  • We streamline workflows to meet your regulatory deadlines without compromising quality.
  • We adhere to ISO 17100-certified workflows, guaranteeing accuracy, consistency, and regulatory compliance.
  • Our multi-step review process, including linguistic validation, back translation, and terminology management, ensures submission-ready documents.
  • Sesen has translated clinical trial protocols, CTD submissions, SmPCs, IFUs, and pharmacovigilance reports for leading life sciences companies.
  • We understand ICH, GxP, MDR, and other international regulatory frameworks, ensuring compliance with global health authorities.
  • We tailor our translation workflows, terminology management, and quality assurance processes to meet your specific regulatory needs.
  • We implement end-to-end encryption, controlled access, and GDPR/HIPAA-compliant workflows to protect sensitive regulatory data.
  • Our secure translation platforms feature audit trails and version control, maintaining document integrity throughout the translation lifecycle.

Sesen’s combination of linguistic expertise, regulatory knowledge, and ISO-certified quality assurance ensures accurate, compliant translations that accelerate approvals and global market access.

Get Started: Request a Free Consultation

Let’s accelerate your regulatory approval process. Request a free consultation today and discover how Sesen can provide high-precision, fully compliant translations for your global submissions.

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