Life Sciences translation and localization solutions for Global Enterprises — Pharma, Clinical Research & Medical Devices

End-to-end multilingual content and localization solutions for pharma, biotech, medical devices and clinical research — delivered by dedicated life sciences experts with deep industry and regulatory knowledge.

Our clients

Regulatory Compliance
Clinical trial expertise
Medical device labelling
80+ languages
ISO certified quality processes
25+ years in Life Sciences
FDA EMA, ICH compliant

Why Life Sciences Localization Requires More Than Translation

In life sciences, accuracy is not a differentiator — it’s a baseline requirement. Content errors don’t just damage reputation. They delay approvals, trigger regulatory queries, and in patient-facing materials, they can cause harm. The challenge for global enterprise is managing this at scale — across multiple languages, markets, regulatory environments and internal teams — without losing control of quality or timelines.

Life sciences content we manage

Clinical research

Protocols, informed consent forms, case report forms, investigator brochures, clinical study reports — prepared for global regulatory submissions and clinical trials in any market.

Medical devices

IFUs, labelling, packaging and technical documentation — compliant with MDR, FDA 510(k) and country-specific regulatory frameworks.

Pharmaceutical

CTD dossiers, SmPCs, PILs, pharmacovigilance documentation, drug labelling and packaging.

Biotech & genomics

Scientific publications, white papers, patent documentation, research summaries.

Patient & COA Content

Patient information materials, consent forms, PRO/ePRO and COA instruments — linguistically validated for clinical accuracy and usability.

Regulatory affairs support

Translation of regulatory correspondence, responses to health authority queries, variations and renewals.

Regulatory submissions

IND, NDA, MAA, CTD dossiers — translated and structured for FDA, EMA, ICH, and local health authority requirements.

Drug labelling & packaging

Accurate translation of labels, inserts and packaging content across all target markets. Full compliance with local regulatory requirements.

Clinical trial documentation

Informed consent forms, protocols, case report forms, investigator brochures — translated with therapeutic area expertise.

Pharmacovigilance

Adverse event reports, PSURs, safety narratives — handled with strict confidentiality, accuracy and audit-ready traceability.

Medical writing support

Publications, white papers, research summaries, clinical and regulatory documentation, patent-related materials.

Training & Compliance Content

SOPs internal documentation, LMS modules and e-learning programs — ensuring consistent global training and compliance alignment.

Digital & Software Localization

Multilingual localization of websites, campaigns, patient engagement materials, SEO content, and digital marketing assets for global life sciences brands.

Software & platform localization

Localization and linguistic testing of medical software, healthcare platforms, mobile apps, ePRO/eCOA systems and user interfaces — ensuring usability, accuracy and regulatory alignment across global markets.

Certified & Notarized Translation

Certified, sworn and notarized translations of regulatory, legal and corporate documents, including apostille processing — for cross-border submissions and authority requirements worldwide.

E-learning localization

Full localization of training modules, LMS content and compliance programs — including text, audio, video and interactive elements — to ensure consistent knowledge transfer across global teams.

Not sure which service fits your project?

Contact a life sciences localization expert

We’ll help you define the right localization approach for your clinical, regulatory or medical content.

Our approach to life sciences localization

Therapeutic area expertise

We assign linguists with proven experience in your therapeutic area — including oncology, cardiology, neurology and rare diseases. No generalists.

Validated terminology management

Your terminology is centrally managed, maintained and enforced across all projects to ensure full consistency across markets and products.

Quality you can measure

Quality is continuously monitored through structured LQA frameworks — delivering measurable performance, not subjective assessment.

Built-In Regulatory Compliance

Our workflows are designed to align with FDA, EMA, ICH and MDR requirements from the outset — not added as a final step.

Full audit trail & traceability

Every asset, change and decision is fully documented to ensure complete traceability for regulatory review and inspections.

Why life sciences companies choose Janus Worldwide

Enterprise life sciences — what full ownership looks like

Industry:

Global biotech company.

Challenge:

Simultaneous submission of CTD dossier in 9 markets — varying regulatory requirements per country.

Solution:

Single dedicated team managing all 9 markets, regulatory review built into workflow, parallel processing.

Result:

Submission accepted first-pass in 7 of 9 markets. 2 minor queries resolved within 48 hours.

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ISO 17100-certified quality processes ensuring consistent, controlled delivery across all projects.

Specialized life sciences linguists with proven expertise in biotechnology, medical devices, diagnostics and healthcare.

Measurable quality performance through Smart LQA monitoring on every project.

Consistent terminology and brand voice maintained across all languages via centralized multilingual style guides.

Full support for regulatory, clinical and scientific communications across the entire product lifecycle.

Enterprise-grade security and compliance including NDAs and secure integrations with client systems.

One partner, one contract, one quality standard — across all markets.

Dedicated support for legal and financial translation trusted by global enterprises and regulated industries.

Scale your life sciences content globally — without losing control

Your project will be done quickly and professionaly


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    Industry
    Information TechnologyLife Science & PharmaManufacturing & EngineeringEnergy & Oil and GasRetail & E-CommerceOther

    Estimated monthly volume
    Less tham 10 000 words/month10 000 - 50 000 words/month50 000 - 150 000 words/month150 000+ words/monthNot sure yet


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