Working Together
Life Science Language Solutions
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.
5,000+
Customers
6
Global Locations
7,500+
Expert Linguists
51+
2025 NPS
ACCREDITATIONS & ASSOCIATIONS
No matter the industry or regulation, you can trust every word.
Regulatory expertise at the foundation of everything we do
Done by experts in your industry, exactly when and how you need it.
Across clinical research, pharmacovigilance, veterinary health, and medical devices, our work is grounded in deep regulatory knowledge. Every translation is aligned with FDA, EMA, and global requirements, supporting accurate submissions, compliant labelling, and audit-ready documentation. We also provide a fully managed translation service for complex filings, including European Marketing Authorization Applications (MAAs).
Clinical & Pharmacovigilance
Translation solutions built for clinical research, pharmacovigilance, and drug safety documentation, ensuring accuracy, regulatory alignment, and clear global communication.
- Clinical trial documentation (protocols, ICFs, IBs)
- Patient-facing materials & recruitment content
- Safety narratives, AE/SAE reports and pharmacovigilance documentation
- Investigator & site communications
Medical Devices
Meet regulatory standards with expert translations for medical device submissions, labelling, and technical documentation.
- IFUs, labeling, packaging & UDI content
- Risk management documentation & clinical evaluation reports (CERs)
- Service manuals, operating guides & technical files
- Post-market surveillance documentation
Regulatory Affairs
We support regulatory teams with accurate, compliant translations across every stage of the authorization process.
- Global submissions (EMA, FDA, PMDA, etc.)
- Module-ready CTD/eCTD components
- Regulatory correspondence & responses
- Quality, safety & compliance documentation
Veterinary
We support veterinary and animal health organizations with accurate, compliant translations that meet regulatory requirements and protect animal welfare.
- Product labels, leaflets & treatment guidelines
- Research papers & scientific reports
- Regulatory submissions for veterinary medicines
- Owner-facing educational and compliance materials
NO MORE WAITING
Benefits of working with BIG Language Solutions.
Easing the pressure on your teams by delivering reliable translations that never compromise scientific or regulatory standards.
Industry Experts
Specialist linguists with deep Life Science knowledge deliver accurate, technically sound translations that reflect scientific intent and regulatory expectations across every therapeutic area.
One Trusted Partner
A single, experienced provider for all translation needs—streamlining workflows, reducing vendor complexity, and ensuring consistent quality across clinical, regulatory, device, and commercial content.
Global & Scalable
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.
Regulatory Ready
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
Language Vault™
Our secure, intuitive, self-service platform for requesting and managing translation projects, giving you full control and efficiency.
One-Stop-Solution
A seamless, single-page experience for translation requests, making it easier to ensure accuracy and efficiency.
Tailored to You
Set retention periods, control access with role-based permissions, and track every stage of the workflow. LanguageVault™ is fully customizable to your requirements.
Full Visibility
Transparent, real-time updates so you can monitor review stages, track timelines, and maintain version control.
Instant, Secure Translation
Instantly generate raw translations using our custom MT engines, all within a controlled environment.
Seamless Integration
Save time by integrating LanguageVault™ with your existing systems.
Custom MT Models
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.
Accuracy & Fluency
Trained on client-specific terminology, tone, and style, reducing errors and ensuring natural translations.
Consistency & Efficiency
Leverages existing TM for uniform output, speeding MT post-editing and keeping rates competitive.
Security
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
Built-In Quality Assurance at Every Stage
ISO 17100 & ISO 9001 Certified
Ongoing Quality Audits
Compliance-Driven
Quality Objectives
Translation Scoring System
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
Industry Insights
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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.