Translating for FDA, EMA, PMDA, and NMPA: Best Practices for Global Regulatory Submissions Globalization has transformed the life sciences industry, with pharmaceutical, biotechnology, and medical device companies increasingly seeking simultaneous regulatory approvals across multiple regions. To support these global submissions, accurate and compliant translation of regulatory documents has become a critical component of the approval […]
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Translation & Localization
Regulatory Translation ServicesMedical & Scientific TranslationClinical Trial TranslationLinguistic Validation ServicesMedical Patent TranslationWebsite Translation & LocalizationLabeling Translation Services
Drug Labeling & Packaging TranslationMedical Device Labeling TranslationIFU (Instructions for Use) TranslationRegulatory Labeling QAHybrid Translation & MTPE
Hybrid Translation (Human + AI)Full MTPE (F-MTPE)Light MTPE (L-MTPE)Regulatory & Scientific MTPESoftware, HealthTech & App Localization
Medical Device Software LocalizationeHealth & mHealth LocalizationClinical & Medical SoftwareAI Healthcare Application LocalizationPatient Portal LocalizationLife Sciences Marketing Translation
Marketing & Commercial TranslationDigital Campaign LocalizationTranscreation & Brand Voice AdaptationMultilingual SEO & Paid SearchMultimedia Localization
eLearning & Training LocalizationVideo Translation ServicesSubtitling TranslationMultilingual Voiceover ServicesAudiovisual Compliance TranslationsInterpreting Services
On-site Medical & Clinical InterpretingRemote & Over-the-Phone Interpreting (OPI, VRI)Simultaneous & Consecutive Conference InterpretingDesktop Publishing (DTP) & Formatting
Multilingual Typesetting & LayoutRegulatory Submission FormattingMedical Packaging Design Localization
- sectors
Pharmaceuticals
Clinical Trial TranslationRegulatory Submission TranslationsDrug Labeling & Packaging TranslationPharmacovigilance & Drug Safety ReportingCMC Documentation TranslationBiotechnology
Scientific Research & Publication TranslationPatent & IP TranslationGenomics & Gene Therapy TranslationBiopharmaceuticals & BiosimilarsPreclinical Research TranslationMedical Devices
IFU TranslationRegulatory Compliance TranslationsTechnical Documentation TranslationSoftware & UI LocalizationCER Translation ServicesCRO
Clinical Study Documentation TranslationPatient Recruitment & RetentioneCOA Translation ServicesGCP Compliance TranslationsClinical Trial Training TranslationHealthcare & Hospitals
Patient-Facing Materials TranslationElectronic Health Records (EHR)Telemedicine & Digital Health TranslationInformed Consent Form TranslationCompliance & Training TranslationRegulatory & Government
Health Authority SubmissionPublic Health & Policy Document TranslationsMedical & Pharmaceutical Legislation TranslationEnvironmental Health & Safety (EHS)International Health Program DocumentationLife Sciences Marketing
Multilingual Marketing & BrandingPharmaceutical & Biotech BrochureMedical Device Marketing TranslationDigital Content & Website LocalizationGlobal Conferences & Event TranslationCertifications & Compliance
ISO 17100 | ISO 9001:2015 | ISO 13485:2016
HIPAA-Compliant Workflows
FDA, EMA, PMDA Regulatory Expertise
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Regulatory & Clinical Solutions
Regulatory & Compliance SolutionsMultilingual support for global submissions, labeling, audits, and SOPs.Clinical Trial EnablementTranslations for ICFs, protocols, site documents, and patient recruitment.Pharmacovigilance TranslationSpecialized translations for AE/SAE reports, DSURs, and safety updates.Label Review & In-Context QAIn-layout linguistic QA for packaging, IFUs, and labeling compliance.Modular Submission & Content ReuseComponent-based translation for IDMP, SPL, and XML content workflows.Commercial & Engagement Solutions
Global Product Launch & Market EntryComprehensive support for launching products in international markets.Patient Engagement & RecruitmentCulturally adapted outreach and multilingual trial communications.Terminology Management & HarmonizationConsistent scientific and brand language across markets.E-Learning & Training LocalizationLocalized training for internal teams, HCPs, and external stakeholders.Website & Digital Experience LocalizationTranslation of websites, portals, and mobile health apps.
- AI
- SesenGPTProprietary language model built for life sciences translation.Agentic AI for Clinical TrialsAutonomous AI for translation workflows across multilingual studies.AI-Powered Human TranslationHuman translation enhanced with AI for speed and consistency.Machine Translation & Post-Editing (MTPE)AI-generated drafts refined by expert linguists.AI for Terminology ManagementAutomated term extraction and consistency across content.
- AI for Project ManagementAI-driven resource matching, scheduling, and QA support.AI for Regulatory & ComplianceSmart automation for labeling and regulatory content.AI for Clinical Trial TranslationFaster, AI-assisted translation of trial documents.AI for Pharmacovigilance TranslationAI-supported workflows for AE reports and safety data.AI for Digital Health LocalizationLocalizing eHealth and mHealth content with AI.
- resources
- Blog & InsightsTrends and expert views on life sciences translation and localization.Case Studies & Success StoriesReal-world examples of successful localization in regulated industries.White Papers & E-booksIn-depth guides on translation strategy, AI tools, and global compliance.
- Webinars & EventsOn-demand sessions and live talks on localization for life sciences.Glossaries & Style GuidesCurated termbases and branded guides for translation consistency.FAQ & Knowledge BaseAnswers to key questions on translation, compliance, and localization workflows.
- about
- Our StoryMission-driven growth rooted in innovation and life sciences expertise.Leadership TeamMeet the executives guiding Sesen’s global localization strategy.Corporate ValuesOur commitment to ethics, transparency, and sustainability in practice.
- LocationsExplore Sesen’s global footprint and key regional office locations.Partners & AffiliationsCollaborations with industry leaders, associations, and tech partners.News & Press ReleasesCompany announcements and media coverage from across the industry.
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