INDUSTRIES > LIFE SCIENCES
Your Trusted Partner for Life Science Translation
SPECIALIZED KNOWLEDGE FOR LIFE SCIENCE TRANSLATIONS
Accuracy, Compliance, & Industry Expertise
Our life sciences expertise ensures accurate, regulatory-compliant translations for clinical trials, medical devices, pharmacovigilance, and global regulatory affairs. We help you accelerate approvals and improve patient outcomes, serving the US, UK, EU, and many more locations.
Clinical Research & Pharmacovigilance
Translation Solutions
We provide accurate, clear translations for clinical trial documents and drug safety monitoring. With deep expertise in clinical research, we ensure compliance and accuracy in every translation including:
- Protocol Synopses
- Instructions for Use
- Investigators’ CVs
- Adverse Event Reports (AERs)
- Patient Diaries & Questionnaires
- Interim/Final Reports
- Drug Labels & Inserts
- Literature Abstracts
- Discharge Summaries
- Electronic Patient Reported Outcomes (ePROs)
- Quality of Life (QoL) Instruments
Medical Device
Translation Services
Ensure your medical devices meet regulatory standards with expert translations for submissions, testing, labeling, and instructions. We meet your requirements by providing fast, accurate, compliant translations to help you launch and maintain devices in global markets including:
- Summaries of Safety and Clinical Performance (SSCP)
- Instructions for Use (IFUs) and Packaging
- Operator’s/Instruction Manuals
- Surgical Brochures
- Patient Leaflets
- Package Inserts & Labeling
- Promotional Materials
- Product Information for Drug/Device Combination Products
- Field Safety Notices
- Software Localization
- Training Materials
- Data Sheets
- Technical Specifications
- Websites
Global Regulatory
Affairs Solutions
Regulatory compliance requires precision. We translate EMA Marketing Authorization Applications (MAAs) using QRD templates to ensure a smooth process. Our project managers work alongside your team every step of the way.
Our team stays ahead of evolving regulations through partnerships with organizations like TOPRA and CCRA, ensuring accuracy in regulatory submissions.
LIFE SCIENCES AND CLINICAL RESEARCH TRANSLATION
End-to-End Language Solutions for Life Sciences
Life sciences such as pharmaceutical and medical device manufacturers require accurate, compliant translations to meet regulatory standards. We deliver expert language solutions for clinical trials, research, medical devices, and pharmacovigilance, ensuring accuracy, efficiency, and global reach.
Patient-Facing
Documents
We translate complex clinical documents and materials into clear, patient-friendly language to improve understanding and make sure you 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. We even provide specialized expertise for EU MAA approval.
- European Medicines Agency (EMA)
- 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
Quality You Can Trust Every Time
With ISO 9001, 17100, and 27001 certifications, we follow rigorous quality processes to ensure every life science translation meets the highest standards. You get consistent, high-accuracy translations tailored to your needs.
Smarter Solutions for Complex 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
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
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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.
