Life Sciences Translation

Life sciences translation for regulated global content.

From clinical trials and regulatory submissions to product labeling and patient communications, LocaTran supports pharmaceutical, biotechnology, medical device, and healthcare organizations in communicating clearly and consistently across Asia-Pacific and global markets. Our services combine qualified linguists, controlled terminology, and documented quality processes.

In life sciences, every word can be consequential.

Life sciences content is subject to rigorous regulatory and quality requirements. An inaccurate dosage instruction, an inconsistent term in a regulatory submission, or an unclear patient-facing message can delay a review, undermine study integrity, or create avoidable patient-safety risks.

Whether you are recruiting participants for a multi-country clinical trial, preparing a dossier for the NMPA, PMDA, or EMA, or localizing the instructions for use (IFU) for a Class III medical device, accuracy and consistency are essential from the outset.

LocaTran combines Asia-Pacific language expertise with documented quality processes for regulated, scientific, and patient-facing content.

From lab to launch — and beyond.

Language support across key stages of the life sciences value chain, aligned with client-provided regulatory specifications and market-specific linguistic and cultural conventions. We coordinate multilingual content for global sponsors entering Asia and for Asia-based innovators expanding worldwide.
Pharmaceutical & Biotechnology
Support across the drug development lifecycle, from preclinical research and clinical trials to regulatory submission, product launch, and post-market activities. Content includes study protocols, Investigator's Brochures, informed consent materials, case report forms, clinical study reports, labeling, and patient communications.
Medical Devices & MedTech
Localization of instructions for use (IFU), user interfaces, software, e-learning, labeling, and post-market content for Class I–III medical devices and in vitro diagnostic devices (IVDs), including content used in MDR, IVDR, and applicable Asian regulatory workflows.
Clinical Research Organizations
Multilingual support for global and regional clinical operations, including site activation, investigator meetings, regulatory correspondence, monitoring documentation, and central laboratory communications.
Healthcare & Hospital Systems
Translation of patient records, hospital websites and portals, clinical training materials, public health communications, and accessible patient information for multilingual and international populations.
In Vitro Diagnostics & Laboratory Sciences
Specialized translation for assay protocols, reagent kits, laboratory software interfaces, and translation and localization of client-provided documentation used in IVDR-related and other market-specific regulatory workflows.

Eight specialized service areas.

Each project is tailored to its purpose, risk level, target market, and client requirements. Regulated and patient-facing content follows a documented workflow that may include translation, independent revision, subject-matter review, proofreading, and final verification.
01
Clinical Trial Translations
Multilingual support for clinical trials across multiple phases and markets.
  • Study protocols and amendments
  • Investigator’s Brochures (IBs)
  • Informed Consent Forms (ICFs) and Participant Information Sheets (PISs)
  • Case Report Forms (CRFs/eCRFs) and Clinical Study Reports (CSRs)
  • Site agreements and ethics submissions
  • Patient diaries, recruitment materials, and lay summaries
02
Regulatory Translation & Submission Support
Translations prepared to support regulatory submissions in global and Asia-Pacific markets.
  • Common Technical Document (CTD/eCTD) modules and summaries
  • Marketing authorization applications
  • NMPA, PMDA, and MFDS submission content
  • Variation and renewal documentation
  • Responses to deficiency letters
03
Medical Device Localization
Localization of labeling, software, and post-market content for medical devices and IVDs.
  • Instructions for use and user manuals
  • Software user interfaces and on-screen text
  • Labeling and packaging
  • Summary of Safety and Clinical Performance (SSCP), where applicable
  • Summary of Safety and Performance (SSP), where applicable
  • Risk management files (ISO 14971)
  • Post-market surveillance reports and periodic safety update reports, where applicable
04
Clinical Outcome Assessment (COA) Linguistic Validation
Linguistic validation and cultural adaptation for patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measures.
  • Concept clarification and translatability assessment
  • Dual forward translation and reconciliation
  • Back translation, harmonization, and cognitive debriefing
  • Coordination with instrument developers and copyright holders, where applicable
05
Pharmacovigilance Translation
Safety-related content translated under agreed turnaround and quality requirements.
  • Individual Case Safety Reports (ICSRs) and Council for International
  • Organizations of Medical Sciences (CIOMS) forms
  • Periodic Safety Update Reports (PSURs) and Periodic Benefit–Risk Evaluation Reports (PBRERs)
  • Safety narratives and labeling updates
  • Adverse event intake and call-center materials
06
Medical & Scientific Translation and Editing
Plain-language adaptation, scientific translation, and editorial support for manuscripts, conference materials, and patient-facing summaries.
  • Plain-language summary translation
  • Patient-facing adaptations
  • Manuscript and journal-article translation and editing
  • Conference abstracts and posters
07
Patient & HCP Communications
Clear, culturally appropriate content for patients and healthcare professionals.
  • Patient education websites and portals
  • Mobile health applications
  • Healthcare professional training materials
  • Marketing content and brand transcreation
08
Medical Interpreting
On-site, over-the-phone, and video remote interpreting for investigator meetings, site audits, patient interviews, and conference sessions. Interpreters are selected for relevant healthcare experience, subject-matter familiarity, and documented qualifications.

Five Quality and Risk Controls for Regulated Content

Life sciences organizations need traceable, auditable language processes. Our approach combines documented workflows, qualified personnel, controlled terminology, risk-based technology use, and disciplined data handling.
01
Certified Quality Systems
Our quality management system is certified to ISO 9001:2015, and our translation services are certified to ISO 17100:2015. Project workflows are tailored to the agreed requirements and may include translation, independent revision, subject-matter review, proofreading, and final verification.
02
Subject-Matter Linguists
Qualified target-language linguists are selected for relevant experience in medicine, pharmacology, biology, biomedical engineering, or regulatory affairs. Depending on the project, linguists may have advanced academic qualifications or relevant clinical, scientific, or industry experience.
03
Terminology Governance
Client-specific termbases and translation memories are version-controlled to help maintain consistency in product names, device components, regulatory phrasing, and approved terminology across documents and project phases.
04
AI-Assisted, Expert-Reviewed
Neural machine translation (NMT) and large language model (LLM) tools are used only in client-approved workflows and where appropriate for the content's risk profile. Human review requirements are agreed before work begins.
05
Confidentiality & Data Handling
Project personnel and suppliers work under contractual confidentiality obligations. Access controls, approved transfer channels, retention requirements, and client-specific data-handling instructions are applied in accordance with the agreed project workflow.

Six reasons life sciences teams choose us

LocaTran combines in-region Asia-Pacific expertise with coordinated global delivery, helping international organizations communicate accurately across Asian markets and supporting Asia-based innovators as they expand into Europe, North America, and beyond.
01
Asian-Language Expertise
Specialist teams support Chinese, Japanese, Korean, and Southeast Asian content across regulated, scientific, and patient-facing use cases.
02
Chinese Translations for NMPA Submissions
Chinese regulatory content is handled by linguists familiar with NMPA-related submission terminology, relevant GB/YY terminology, and client-approved language requirements.
03
Coordinated Two-Way Market Support
One coordinated team supports international organizations entering Asian markets and Asia-based innovators expanding into Europe and North America.
04
Scalable Global Delivery
We support multi-country trials and submissions across 150+ languages, coordinated by a designated project lead, supported by the appropriate production and quality teams.
05
Risk-Based Use of AI
AI and machine translation are applied only in approved workflows. Human review requirements are defined according to the content type, risk level, and agreed workflow.
06
Documentation to Support Supplier Qualification and Audits
Traceable QA records, terminology controls, and agreed supporting documentation can be made available for supplier qualification and client audits, subject to project scope, retention requirements, and confidentiality obligations.

The questions life sciences buyers ask us

Procurement, quality, and regulatory teams need clear answers before they engage a language partner.
Here are the questions we hear most often.
How do you select linguists for life sciences projects?
We assign qualified target-language linguists based on language proficiency, locale, relevant subject-matter background, and documented experience with the content type and target market. Many have advanced degrees or direct clinical or industry experience.
Do you follow an ISO 17100 translation process?
Our quality management system is certified to ISO 9001:2015, and our translation services are certified to ISO 17100:2015. Regulated and patient-facing projects follow documented workflows tailored to the agreed requirements. These workflows may include translation, independent revision, subject-matter review, proofreading, and final verification.
Can you support our supplier qualification and audits?
Yes. We complete relevant quality and security questionnaires, provide applicable process documentation under confidentiality, and support client supplier-qualification and audit requirements.
How do you handle confidential and patient data?
Personnel and suppliers work under contractual confidentiality obligations. We apply access controls, approved transfer channels, defined retention periods, and client-specific data-handling requirements in accordance with the agreed project workflow. Data-processing terms and in-region handling requirements can be discussed during project qualification.
Do you use machine translation or AI on life sciences content?
Only in client-approved workflows and where appropriate for the content's risk profile. Machine-assisted output receives the agreed level of human review before delivery, and regulated or patient-facing content is handled according to the project's approved quality and risk requirements. We do not use free or public AI tools for confidential client content.
How do you manage MedDRA, WHODrug, and client terminology?
We use client-approved versions of applicable terminology resources, including MedDRA, WHODrug Global, EDQM Standard Terms, SNOMED CT, and LOINC, where licensed and relevant. Client-specific terminology is maintained in dedicated termbases, while approved bilingual content is stored in client-specific translation memories.
Can you support COA linguistic validation and back translation?
Our COA workflows can include concept clarification, dual forward translation, reconciliation, back translation, harmonization, and cognitive debriefing for patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measures. Coordination with instrument developers and copyright holders is available where applicable.
Which regulatory markets do you support?
We support content prepared for submissions across Greater China (NMPA), Japan (PMDA), South Korea (MFDS), Europe (EMA, MDR/IVDR), the United States (FDA), and other Asia-Pacific markets. Regulatory decisions remain with the relevant authorities; our role is to provide accurate, consistent, and well-documented language support.