Global Regulatory Solutions

As pharmaceutical and medical device companies expand to provide global distribution of medicines, products, and services, compliance with both timelines and regulatory guidelines is critical to avoiding delays or losing a spot in the release cycle.

Manage Regulatory Processes on a Global Scale

In the pharma and medical device industries, providing quality, on-time submissions and documentation 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, our services can help you provide quality submissions to local regulatory bodies, on time, 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:

  • Specialised teams of global regulatory professionals, subject matter experts, language leads, translators, writers, and proofreaders, plus dedicated project managers available whenever you need them, all in your own language
  • A broad range of multilingual regulation compliance services, from translation to label creation, from formatting (desktop publishing) to independent review
  • A certification and validation programme that is recognised 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. We provide an easy-to-implement, flexible solutions for multilingual asset management (translation memories, glossaries, style guides), streamlined in-country language review processes and integration with labelling, as well as other Content Management Solutions and authoring tools.

With our labelling and packaging solutions, you can gain access to:

  • Global experts with deep knowledge of life sciences translation and regulations, from initial product submissions to production-ready labelling
  • High-quality labelling and packaging services, including artwork preparation (labels and secondary packaging components), Structured Product Labelling (SPL), labelling 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.

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Anatomy of a Clinical Label

"One of the most critical components to think about is clinical labeling. First things first: what does a compliant clinical trial label look like?"

Anatomy of a Clinical Label 01/08/2017