Global Regulatory Solutions

As pharmaceutical and medical device companies expand distribution of medicines and products around the globe, compliance to timelines is critical to avoiding delays or losing a spot in the release cycle.

Successfully manage approvals across geographies

In the pharma and medical device industries, providing quality, on-time submissions to local regulatory bodies is probably the single most important part of your business. Navigating the labyrinth of country-specific regulatory submissions can take weeks or even months.

At Lionbridge Life Sciences, we can help you provide on-time quality submissions to local regulatory bodies—every time. Our dedicated project management and language supply chain teams focus on two things for both pharma and medical device clients: Readiness and delivery.

Our Global Regulatory Solutions rely on a network of extremely qualified medical resources, each with years of direct experience working with local Health Authorities around the world (the European Medicines Agency [EMA], China’s SFDA, Japan’s PMDA, and South Korea’s KFDA, to name a few).

We adhere to validated certifications and rigorous methodologies to deliver high-quality regulatory translation services and strategy, while focusing on fast turnaround times to help you comply with the ever-changing, ever-challenging global regulatory environment.

Our capabilities include:

  • Specialized teams of global regulatory professionals—subject matter expert reviewers, language leads, translators, writers, and proofreaders—plus dedicated project managers available 24/7, in your language
  • A broad range of multilingual regulatory compliance services—from translation to label creation, from formatting (desktop publishing) to independent review
  • A certification and validation program that is recognized and praised by local health authorities
  • Dedicated graphic engineering resources that ensure regulatory formatting compliance

You can also take advantage of technology as a managed service, an easy-to-implement, flexible solution for multilingual asset management (translation memories, glossaries, style guides), streamlined in-country language review processes and integration with labeling, and other Content Management Solutions and authoring tools.

With our labeling and packaging solutions, gain access to:

  • Global experts with deep knowledge of life sciences translation, from initial product submissions to production-ready labeling
  • High-quality labeling and packaging services, including artwork preparation (label, secondary packaging components), Structured Product Labeling (SPL), labeling updates and amendments, Product Information Leaflets (PIL), patient handbooks, data sheets, user guides, technical manuals, and software
  • Innovative technology, such as SaaS-based tools for project submission, linguistic asset management, and reporting that can improve cost efficiencies and accelerate timelines

Lionbridge Life Sciences is ready for you in every way—ready to deploy fully integrated solutions with a proven, rigorous process. Ready to scale globally and deliver locally. Ready to provide the multilingual regulatory and subject matter expertise you need to stay ahead.

case study

Global Regulatory Solutions: Case Study

Challenge
Solution
Result

As dispensary growth and state mandates for language requirements have accelerated, one of America’s largest pharmacy services providers wanted to implement a comprehensive review of its prescription labeling. Some of the issues we had to solve for included:

  • 10-15 languages are required in some states to meet the needs of culturally diverse patient populations
  • There are complex compliance verifications (e.g., labeling, drug interactions, patient privacy) as an Rx gets filled
  • Content had a high level of inconsistency across labels due to varying prescriber instruction terminology
  • There was no standardized English instructions for use (IFU) phrase library
  • Patient safety needed to be the primary concern

First we ran a comprehensive Rx compliance and label review. Then we conducted an audit of English source content to verify indication instructions against FDA-cleared IFUs.

This lead to the creation of a standardized IFU phrase library, validated by language and reflecting grammatical nuances. Finally, we oversaw an integration of an automated, centralized translation workflow into a customer Rx platform, which increased uniformity and accuracy.

  • Achieved label standardization, compliance, and accuracy thresholds 100%
  • Increased comprehension of label IFUs for improved patient safety and quality care
  • Improved process efficiency gains
  • Achieved 100% transparency into all projects, costs and KPIs
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"Translation as a business service is one such solution that plays a key role in all stages of the drug development cycle – including R&D, clinical trials, go-to-market strategy and regulatory compliance"

Navigating Drug Development with Translation Solutions 6/3/2016