Pharmaceutical Regulatory Translation Services for Smoother, Successful, and Compliant Regulatory Affairs

Ensure Compliance with Pharmaceutical Regulatory Translation Services

Run compliant regulatory affairs more easily with outstanding life sciences translation services and linguistic support for product information and other regulatory documentation translation needs.

Our regulatory solutions provide customers with accuracy and precision at scale and at speed. We’re deeply experienced in translating product information and other regulatory documentation, while simultaneously meeting steep regulatory compliance requirements.

Service Areas

Labelling

We’re a specialist provider of product information pharmaceutical translations for new marketing authorization applications and post-approval procedures. You can rely on our expertise in the European Union linguistic review process and regulatory requirements in other jurisdictions. We deliver translation solutions with minimum customer burden and optimum language asset usage. Your solutions are always tailored to your needs, capacities, and internal regulatory infrastructures.

Regulatory Affairs

We understand a new filing is a significant undertaking, requiring domain expertise and efficient management of regulatory information. Our life sciences translation services use AI-driven translation tools to process high-content volumes and ensure translation accuracy, consistency, and faster turnaround times. Our advanced project planning drives agile, on-time delivery. We minimize potential bottlenecking and reduce crunch time in dossier preparation. Lionbridge’s global operating model allows project oversight within required regions, ensuring expedited responses for time-sensitive application review communications.

Safety

Lionbridge is a global language service provider offering high-capacity, resilient, and time-efficient translation services to support safety reporting across different regulatory regions and languages. We process life sciences translations with expert consideration of requirements for standardized medical terminologies and vocabularies, formats, forms, and templates. Lionbridge delivers with the utmost quality and speed, regardless of scale.

Linguistic Review Process for EU Drug Labeling

Drugs authorized in the EU go through a strict Linguistic Review process. Understand the process and why translation quality is vital for approval.

Lionbridge’s Pharmaceutical Translation Services Thought Leadership

We understand your industry’s complexities and regulations. More from our experts:

From Clinical Trials to Launch: The Drug Development Process

Learn how the development of a new drug progresses from clinical trials to approval and deployment—and how Lionbridge Life Sciences can assist with your communication needs.

Smart Sourcing for Language Service Provider Selection

Language and data privacy requirements are stricter and more prescriptive across regulatory regions. Learn how Lionbridge’s pharmaceutical translation services can help you navigate these challenges.

Machine Translation as a Service in Life Sciences

Machine translation has become crucial for life sciences organizations, with daily use of AI embedded in many critical processes.

Lionbridge Laⁱnguage Cloud™: Is Machine Translation Getting Better?

Discover how Laⁱnguage Cloud™ automates translation and lets your Life Sciences company focus on business growth.

Language Planning Guidance for Multi-Regional Clinical Trials and ICH E17

Learn 5 critical tips from Lionbridge’s life sciences translation team for optimal language planning for multi-regional clinical trials and ICH E17.

Writing Clinical Trial Results for Multi-Regional Clinical Trials

Understand essential considerations for writing more effective clinical trial results for multi-regional clinical trials.

Plain Language Writing, the FDA, and Vaccination Hesitancy

Learn about the FDA’s urging for more plain language writing, which is meant to fight an alarmingly widespread vaccine hesitancy.

Get in Touch

Send a message about how we can assist with your pharmaceutical translation services needs.

If you’d like to apply to work for Lionbridge, please visit our Join Our Team page.

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