INDUSTRIES > LIFE SCIENCES
Your Trusted Partner
for Life Science
Translation Services
We provide translation services for life sciences, pharmaceutical, and biotech organizations, offering customizable end-to-end language solutions designed for large-scale, time-sensitive, and complex subject matter translations.
We work closely with regulatory bodies, reviewers, and stakeholders to deliver integrated, bespoke translation services suitable for your industry and project. With 60 years of expertise, our life science linguists and project managers ensure accuracy, compliance, and seamless global communication.
SPECIALIZED KNOWLEDGE FOR LIFE SCIENCE TRANSLATIONS
Accuracy, Compliance, & Life Sciences Expertise
Our life sciences expertise ensures accurate, regulatory-compliant translations for clinical trials, medical devices, pharmacovigilance, and global regulatory affairs. We help you deliver large-scale multilingual projects effectively, streamline communication, and accelerate approvals, serving the US, UK, EU,
and many more locations.
Pharmaceutical Translation:
From Development
to Pharmacovigilance
Our translation services support the entire product development lifecycle, from early research and development through regulatory approval and post-market activities, including clinical trial document translation and pharmacovigilance translation services, such as:
- Protocol Synopses
- Adverse Event Reports (AERs)
- Periodic Safety Update Reports (PSURs)
- Interim and Final Study Reports
- Drug Labels & Package Inserts
- Summary of Product Characteristics (SmPCs)
- Patient Information Leaflets
- Electronic Patient Reported Outcomes (ePROs)
- Quality of Life (QoL) Instruments
We ensure alignment with regulatory frameworks such as QRD templates and International Nonproprietary Names (INN), supporting both approval
and ongoing drug safety monitoring.
Medical Device
Translation Services
Our subject matter linguists are proficient in navigating global regulatory documentation required for medical devices, including EU MDR and IVDR, where accuracy directly impacts market access and patient safety.
We support medical device development and manufacturing
with translations for:
- Instructions for Use (IFUs) and labeling
- Summaries of Safety and Clinical Performance (SSCP)
- Technical files and risk management documentation
- Software localization for device interfaces
- Declaration of Conformity documents
- Post-market surveillance reporting
Biotechnology
Translation Services
Our linguistics translators are subject matter experts to ensure proficiency in navigating complex life science sectors, including biologics, biosimilars, and genetic research. We also support biotechnology-related submissions, including linguistic preparation for global filings.
We translate documentation including:
- Scientific publications and peer-review documents
- Patent applications and technical disclosures for international IP protection
- Documentation for In Vitro Diagnostics (IVD)
- Research proposals for international grants
- Technical specifications for bioprocessing and laboratory equipment
Veterinary Translation Services
We provide specialized, subject-matter expert translators in veterinary medicine, veterinary pharmaceuticals, and animal welfare, covering documentation including:
- Product labels and leaflets for veterinary pharmaceuticals
- Research papers and scientific reports in animal healt
- Owner-facing educational and compliance materials
- Regulatory submissions for veterinary medicines to international bodies
Global Regulatory Affairs Solutions for Life Sciences
Our teams stay aligned with evolving regulatory requirements through partnerships with organizations like TOPRA and CCRA, ensuring submissions meet the linguistic and structural expectations of each market. We translate sensitive regulatory documents, including:
- Marketing Authorization Applications (MAAs)
- Regulatory correspondence with global authorities
- Labeling and product information updates
- QRD-compliant submissions
LIFE SCIENCES AND CLINICAL RESEARCH TRANSLATION
End-to-End Language Solutions for Life Sciences
At BIG Language Solutions, we work with life sciences organizations requiring accurate, compliant translations across multiple functions, from research and clinical development to commercialization and post-market surveillance.
We provide integrated language support across departments, ensuring consistency between clinical, regulatory, and commercial content. Our translation solutions serve over 300 languages – get in touch to enquire about language availability for life science translations.
Patient-Facing
Documents
We translate complex clinical documents and materials into clear, patient-friendly language to improve understanding and maintain compliance.
- Informed Consent Forms (ICFs)
- Lay Summaries
- Patient/Doctor Information Sheets
- Appointment Reminders, etc.
Physician-Facing
Materials
Accurate translations for physicians, researchers, and administrators. Ensure all your communication is clear and adheres to regulations for complete compliance.
- Clinical Study Protocols
- Investigator Brochures (IBs)
- Ethics Committee Letters
- Case Report Forms, etc.
- Clinical Outcome Assessments
Regulatory
Affairs
Our life science translation services ensure compliance with EMA, FDA, and international regulatory bodies. Additionally, we provide specialized expertise for EU MAA approval.
- Marketing Authorization Applications
- QRD-compliant Submissions
- Labeling & Product Information
Comprehensive Language Solutions
for Life Sciences
Expert Language Solutions for Life Sciences
Trusted by Life Science Leaders
Accuracy and compliance matter in life sciences. We deliver expert translations that meet strict regulatory standards, helping you bring innovations to market faster while ensuring patient safety.
Stay on Track Without Delays
Our expert linguists and proactive project managers give hands-on support and work closely with regulatory bodies, reviewers, and stakeholders to ensure seamless, efficient workflows.
Quality You Can Trust Every Time
With ISO 9001, 17100, and 27001 certifications, we follow rigorous quality processes required for life sciences translations.
Smarter Solutions for Complex Projects
For suitable content, we combine structured workflows, controlled use of Neural Machine Translation with expert linguistic review, ensuring both efficiency and accuracy across large, multilingual projects.
“Our reviewers complimented the translations you did. Our Romanian
reviewer said it was one of the best
they had ever reviewed.”
Regulatory Affairs Manager
Global Life Sciences Organization
ACCREDITATIONS & ASSOCIATIONS
BIG Language Solutions’ Professional
Certifications & Memberships
FEATURED
Life Sciences Industry Insights
Clinical Trial Translation: Are You Compliant With the EU CTR?
Identifying translation needs at the outset of new clinical trial studies will help organizers comply with the translation requirements of the EU Clinical Trials Regulation
Electronic Product Information: How to Ensure Compliance with European Medicine Agency Guidelines
European Medicine Agency guidelines for electronic product information will soon apply to all medicines prescribed or dispensed in the European Union. This blog explains the
The Importance of Translation to the Medical Device Market
In a recent article for MedCityNews, M&A specialist David Magnani outlined the top 7 challenges facing the medical device market. The global medical device market
CONTACT US
See how BIG can work for your business
Need expert language access solutions for your business?
From translation and interpretation to alternate formats and global compliance, we’ve got you covered.
Contact us today to see the difference BIG Language Solutions can make.
Frequently Asked Questions About Life Sciences Translation Services
We work with pharmaceutical companies, biotechnology firms, medical device manufacturers, CROs, and regulatory consultancies, supporting each with tailored language solutions based on their specific requirements.
BIG Language Solutions achieves accuracy through a multi-stage Quality Assurance (QA) process that adheres to ISO 17100 and ISO 13485 standards.
We utilize a “dual-review” system where advanced Neural Machine Translation is paired with linguistic review by specialists who have deep subject matter expertise in the specific therapeutic area or technical field.
Centralized terminology management and AI-powered glossaries further ensure that complex drug names, measurements, and regulatory terms remain consistent across all documents.
Yes. All our translation workflows and technological platforms are built with a security-first framework. We are ISO 27001, SOC 2 Type II, and HITRUST certified, ensuring that all Protected Health Information (PHI) is handled through encrypted data transmission and secure, access-controlled portals like LanguageVault®. We also offer automated PII redaction to further safeguard sensitive information in compliance with global privacy laws.
Yes. We provide translation support for EMA, FDA, and other international submissions, ensuring compliance with local linguistic and formatting requirements.
Our LanguageExpress™ platform is specifically designed to manage high-volume, repeatable content with automated workflows.
This allows us to process thousands of pages of clinical study reports, module-ready CTD components, and regulatory correspondence with predictable turnaround times that meet the tight deadlines of the authorization process.
Our life sciences translation services cover early research, clinical development, regulatory approval, and post-market activities, ensuring continuity across all stages. Learn more about our clinical trials translation services.
We use structured workflows and apply Neural Machine Translation selectively for appropriate content types, enabling faster turnaround while maintaining quality through expert review.
Yes. We support regulatory teams with accurate, compliant translations for every stage of the MDR process. This includes translating technical documentation, Instructions for Use (IFUs), Clinical Evaluation Reports (CERs), and post-market surveillance data, ensuring all materials meet the specific linguistic and regulatory requirements of the European Union member states.
Clinical translation focuses specifically on in-trial documentation and workflows, while life sciences translation encompasses the broader ecosystem, including regulatory, medical device, and post-market content. Explore our clinical trials translation services.