Working Together
BIG Language Solutions partners with Life Science organizations as an extension of their regulatory and clinical teams, bringing deep subject-matter expertise, rigorous quality management, and processes built around the full product lifecycle.
Customers
Global Locations
Expert Linguists
2025 NPS
Regulatory expertise at the foundation of everything we do
Across clinical research, pharmacovigilance, veterinary health, and medical devices, our work is grounded in deep regulatory knowledge. Every translation is alignedwith FDA, EMA, and global requirements, supporting accurate submissions, compliant labelling, and audit-ready documentation. We also provide a fully managedtranslation service for complex filings, including European Marketing Authorization Applications (MAAs).
Translation solutions built for clinical research, pharmacovigilance, and drug safety documentation, ensuring accuracy, regulatory alignment, and clear global communication.
Meet regulatory standards with expert translations for medical device submissions, labelling, and technical documentation.
We support regulatory teams with accurate, compliant translations across every stage of the authorization process.
We support veterinary and animal health organizations with accurate, compliant translations that meet regulatory requirements and protect animal welfare.
NO MORE WAITING
Easing the pressure on your teams by delivering reliable translations that never compromise scientific or regulatory standards.
Specialist linguists with deep Life Science knowledge deliver accurate, technically sound translations that reflect scientific intent and regulatory expectations across every therapeutic area.
A single, experienced provider for all translation needs—streamlining workflows, reducing vendor complexity, and ensuring consistent quality across clinical, regulatory, device, and commercial content.
Onshore and offshore teams combine speed, capacity, and controlled costs, enabling reliable multilingual support for high-volume programs, tight timelines, and complex global project demands.
ISO-aligned, audit-ready processes ensure accurate, compliant translations for submissions, labeling, safety reports, and technical documentation—reducing risk and supporting smooth regulatory approvals.
Translation Management Platform
Our secure, intuitive, self-service platform for requesting and managing translation projects, giving you full control and efficiency.
A seamless, single-page experience for translation requests, making it easier to ensure accuracy and efficiency.
Set retention periods, control access with role-based permissions, and track every stage of the workflow. LanguageVault™ is fully customizable to your requirements.
Transparent, real-time updates so you can monitor review stages, track timelines, and maintain version control.
Instantly generate raw translations using our custom MT engines, all within a controlled environment.
Save time by integrating LanguageVault™ with your existing systems.
BIG Language Solutions trains custom MT models using each client’s TM—a database of all finalized translations. Our advanced training methods deliver highly accurate, efficient, and secure translations.
Trained on client-specific terminology, tone, and style, reducing errors and ensuring natural translations.
Leverages existing TM for uniform output, speeding MT post-editing and keeping rates competitive.
Client data is private; model is trained exclusively for their use.
WHAT OUR CUSTOMERS THINK
“Our reviewers complimented the translations you did. Our Romanian reviewer said it was one of the best they had ever reviewed.
Regulatory Affairs Associate
Global Clinical Research Organization
AUDITED & CERTIFIED
Every project undergoes multiple layers of review. Errors are logged, categorized, and scored. Corrective actions are taken based on results to continuously improve quality. Scoring adds objectivity, helping teams identify patterns across languages, document types, and linguists. Results inform targeted coaching, process adjustments, and vendor performance management. Over time, this reduces rework, improves consistency, and strengthens outcomes at scale.
FEATURED
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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.
