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No More Regulatory Delays for Critical Language Outcomes
Expert-led, submission-ready regulatory translation services for any submission or procedure.
Rely on us for language outcomes to support clinical trial applications, regulatory filings, safety reporting, or post-market commitments.
Lionbridge has supported clinical trial applications and regulatory submissions with precision and speed for decades. We understand the potential implications of a delay or rejection. Our teams bring expertise with all US and EU Regulations. They support both centralized and decentralized procedures throughout the product life cycle.
Centralize your regulatory translations, medical device translations, pharmaceutical translations, and linguistic validation projects with Lionbridge. Never miss a regulatory submission again.
Clinical Regulatory Translation Services
Clinical Translations
Ensure clinical trial applications are on time for all countries where you execute clinical programs and recruit trial participants. Partner with Lionbridge to:
- Secure all language outcomes ready for simultaneous submission, irrespective of how many countries or which trial designs
- Swiftly respond to language queries from National Competent Authorities or Ethics Committees
- Intelligently leverage AI-powered translations under human control across clinical development programs
Clinical Labeling
Obtain regulatory validated labels with Lionbridge’s clinical labeling services. Ensure labels are on time, compliant, and accurate in all languages across clinical programs. Lionbridge provides global coverage for Investigational Medicinal Products (IMPs) and submission-ready country labels in all countries. We validate pharmaceutical master labels for clinical trials and Early Access Programs (EAPs) in compliance with Good Manufacturing Practice and country-specific legislation.
Regulatory Labelling
Meet the strict regulatory timelines and EU Linguistic Review requirements for your regulatory labeling. Language is critical for timely regulatory filing and marketing authorization. We've supported regulatory labeling and filing for decades. Our team supports all types of labeling language outcomes, whether for initial or updated marketing authorizations, Centralized, or National type procedures.
COAs
With a strong portfolio of Clinical Outcome Assessment (COA) services, Lionbridge helps clinical trial sponsors generate important patient-reported, clinician-reported, observer-reported, and performance-reported outcomes. Our services include:
- Translations and linguistic validation services in conformance with applicable best practice guidelines
- Copyright and licensing support services
- Usability testing and linguistic migration services
Whether your outcomes are for confirmatory or exploratory purposes, we can help.
Global Regulatory Solutions – Clinical Labeling Services
Watch the video to discover how integrated workflows and automation can transform clinical labeling for investigations in all territories.
Insights From our Regulatory Translation Experts
Regulatory Translation FAQs
I have an extensive clinical development program planned across multiple regions and patient populations. How can Lionbridge support my program execution?
Lionbridge’s experts on clinical content can help you set up an AI-powered language strategy to secure speed and precision in all language outcomes for the most demanding and complex clinical programs. We work across all therapeutic areas, clinical trial phases, designs, and regulatory territories.
How does Lionbridge ensure the quality I need for regulatory submissions?
Lionbridge Life Sciences is ISO-certified and maintains a dedicated Quality Management System for our regulated services.