Life science translations

Janus Worldwide has remained a trusted partner for customers in the field of life sciences for over 29 years, having demonstrated the translation and localization proficiency required to provide services for global clinical trials, medical devices and healthcare brands, as well as for pharmaceutical, biotech and medical companies.

We offer support in all linguistic areas, from the localization of clinical trial documentation and clinical assessments to regulatory translations for pharma and medical devices companies.

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You can rest assured that our team of skilled project managers and translators have extensive expertise in the life science industry, and will get the job done in the shortest time possible and within your required budget. We provide language translation services in over 100 languages to clients operating in highly regulated industries, and make use of our Global Technology Platform to ensure accurate and timely project delivery.

Our distributed team is familiar with local regulations and market practices, which helps us account for cultural context and local regulatory specifics. In addition to written translation, we provide interpreting services for clinics and research centers.

Marketing and training materials, information content for sites, legal and regulatory documentation does not form a complete list of things that fall into the hands of our company’s specialists. In addition, we are also ready to help you with translation and localization:

Informed Consent Forms (ICFs)
Regulatory Submission Documents
Labeling & Packaging Inserts
Patient Information Leaflets (PILs)
Pharmacovigilance Reports
Data sheets

Case Reports
Clinical Trial Protocols
Instructions for Use (IFUs)
Standard Operating Procedures (SOPs)

At Janus, we use cutting-edge technologies for top-quality medical translations. Our Global Technology Platform (GTP) simplifies project management, ensuring real-time updates and efficiency. With automation development, we optimize workflows, minimizing errors and boosting speed.

Our MAIA AI ecosystem automates and enhances translation, formatting, communication, and project management processes, integrating seamlessly with corporate systems.

Additionally, LEXA, our customizable machine translation platform powered by Janus NMT, is tailored to the medical and life science spheres, ensuring precise, high-quality translations for complex content.

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LANGUAGE TRANSLATION SERVICES: FROM USER MANUALS TO CLINICAL STUDY PROTOCOLS AND OTHER REGULATORY DOCUMENTATION

Here are some important use cases where Automated/AI translation can make a difference in life sciences and pharmacovigilance:

Case Reports: Ensuring accurate communication of findings.
Internal Documents: Facilitating clear understanding among team members.
Emails and Correspondence: Streamlining communication across diverse teams.
Regulatory Documents: Meeting compliance standards effectively.

QUESTIONS AND ANSWERS

Can you handle urgent projects?

Yes, in the context of rush/urgent projects, it is invaluable that our project manager connects us with highly skilled vendors who are well-suited for the tasks required. We remain attentive to deadlines, and ensure that updates are consistently shared with the team. Our project management tools greatly assist us in tracking progress and fostering effective communication with translators.

How do you handle confidentiality?

Do you use qualified translators and post-editors?

At Janus, we recognize the critical importance of selecting the right linguists for each Life Science project. Our selection process ensures that we connect your project with translators who meet the following qualifications (we utilize a vendor auto-suggestion tool to identify the most suitable vendors among available suppliers):

Subject Matter Expertise: We thoroughly assess each linguist’s knowledge and experience in the specific life science field relevant to your project.
Experience with Life Science Translations: We prioritize linguists with a proven track record of delivering high-quality translations in the life science industry. This experience includes working on clinical trial documentation, regulatory submissions, scientific publications, and marketing materials.
Cultural Understanding: We take into account the cultural context of your target audience and select linguists who are knowledgeable about the cultural nuances and linguistic conventions of the region.
Quality Assurance: our linguists adhere to strict quality standards and undergo regular evaluations to ensure their continued competence. We also implement rigorous quality control measures throughout the translation process.
Technical Background: We ensure that our linguists are proficient in the tools required and have experience working with them.

What types of medical documents can Janus translate?

Our medical document translation services cater to a diverse range of healthcare documents that require specialized knowledge and adherence to regulatory compliance. Common examples include:

Clinical trial protocols and reports
Informed Consent Forms (ICFs)
Patient Information Leaflets (PILs)
Summary of Product Characteristics (SmPC)
Instructions for use (IFUs)
Regulatory submissions (e.g., EMA, FDA)
Pharmacovigilance reports
Medical device documentation

What are your prices?

The cost of language services varies greatly. Project pricing depends on several key factors, such as:

Word Count
Language Pair
Service Type e.g. translation only, DTP
Turnaround Time
AI – with the AI ecosystem, some cost efficiencies may be passed on to clients

We highly recommend sending us the content for translation to receive a detailed quote that explains what is included.

What’s the difference between the types of translation you can order: Human or AI?

How do you ensure compliance with QRD template requirements across all EU/EEA languages? Could you describe your multilingual QRD update process, including how you manage terminology control, formatting, and final deliverables?

QRD Multilingual Update

Ensuring that product information fully complies with latest QRD template requirements across all EU/EEA languages is a critical step in the marketing authorization process. Even minor inconsistencies, such as variations in headings, units, or standard phrases, can result in non-compliance findings, repeat correction rounds, and delays in regulatory approval.

Our approved QRD Multilingual Update process ensures complete alignment of the Summary of Product Characteristics (SmPC), Package Leaflet (PL), and annexes with the latest QRD template and applicable regulatory requirements, both in structure and content. Updates are implemented consistently across all required EU/EEA languages, based on a single approved English master, while maintaining semantic equivalence and full traceability throughout document and artwork versions.

Regulatory compliance and terminology control

All EDQM Standard Terms (pharmaceutical form, route of administration, and product presentation) are updated in accordance with the latest official lists. Mandatory QRD phrases and warnings, including those concerning excipients with known effects or other standardized statements from the QRD Annex, are implemented globally using the required wording.

Consistency, formatting, and readability

All multilingual versions are verified for alignment with QRD conventions, including heading hierarchy, table structure, numbering, units and decimal formats (e.g. mg/mL), and standardized capitalization. This ensures a uniform document structure and readability across languages.

Deliverables

Final QRD-compliant SmPC and annex files are delivered ready for submission to competent authorities. Each multilingual version is fully traceable to the approved English source and demonstrates complete conformity with the latest QRD template. Updates are performed by a team with expertise in regulatory documentation, QRD implementation, and linguistic validation across all EU/EEA languages.

This approach ensures consistent, audit-ready output that meets EMA expectations and eliminates authority comments such as “Please align to QRD.” The result is a clear set of documents ready for submission, reflecting best regulatory practice and a robust quality control process.

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At Janus Worldwide, every client’s project is handled with the utmost care and confidentiality. Our ISO-certified processes (ISO 9001, ISO 17100, ISO 27001) ensure top-tier quality and data security at every step. Leveraging decades of industry expertise and innovative platforms like GTP and Smart LQA, we deliver tailored solutions that meet each client’s unique requirements—safely, securely, and always on time.

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At Janus Worldwide, we treat every client as a valued partner. Our dedicated customer support teams ensure seamless, round-the-clock communication and quick responses to every request. We believe in building trust through transparent processes and open dialogue at every project stage. With decades of expertise and a commitment to excellence, we deliver high-quality services tailored to each client’s needs, ensuring their satisfaction and long-term success.

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At Janus Worldwide, we value our team as our greatest asset, fostering growth, trust, and continuous learning. Our talented linguists are native speakers and certified experts who guarantee human translation of the highest quality. For efficiency and flexibility, clients can choose our in-house GTP platform for machine translation with expert post-editing, or leverage our AI-powered MAIA system for smart, cost-effective solutions—always tailored to meet diverse content and quality needs.

Case Studies