Regulatory

Regulatory_InsetImage_MainThe only constant in today’s evolving global regulatory environment is that local Health Authorities expect on-time quality submissions – each and every time. 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. That’s why our dedicated project management teams focus on one thing: Readiness. Lionbridge Life Sciences is ready to deploy fully integrated solutions and a proven, rigorous process. Ready to scale globally and deliver locally. Ready to provide the multilingual regulatory and subject matter expertise your company needs to stay ahead. Here’s how:

Global Regulatory Solutions | Labeling & Packaging
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Global Regulatory Solutions

Our highly experienced Global Regulatory Solutions (GRS) team is focused on helping our partners meet all their multilingual regulatory documentation requirements. Whether you are about to embark on a clinical trial across Asia or register your product within the European Union (EU), we will ensure on-time quality deliveries all the time.

GRS relies 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, South Korea’s KFDA, to name a few). We adhere to validated certifications and rigorous methodologies to deliver high-quality translation services and strategy, while focusing on fast turnaround times to help you comply with the ever-changing, ever-challenging global regulatory environment. We offer:

  • A specialized team of global regulatory professionals – Subject Matter Expert Reviewers, Language Leads, Translators, Writers, Proofreaders, – plus dedicated project managers available 24/7, in your language
  • A broad range of multilingual regulatory compliance services – from translation to writing, from formatting (desktop publishing) to independent review
  • A Certification and Validation program that is recognized and praised by the Local Health Authorities
  • Dedicated graphic engineering resources that ensure regulatory formatting compliance

We also provide technology as a managed service for easy implementation and flexibility, including Multilingual Asset Management (translation memories, glossaries, style guides, artwork), streamlined in-country language review processes and integration with labeling and other Content Management Solutions and authoring tools.

Pharma.Biotech.CRO_IconPharmaceutical, Biotechnology & CRO

Because the quality expectations of the local Health Authorities have never been higher, whether you are managing Clinical Labels or Product Registrations above all you need a partner that can help you guarantee multilingual regulatory compliance and on-time delivery.

Our Global Regulatory Solutions (GRS) team was built from day one to support the specific multilingual challenges that all Regulatory Affairs Leaders face when conducting their business in the world’s markets, including:

  • Scale: our dedicated team is composed of thousands of highly specialized and qualified resources covering in excess of one hundred different countries and languages, and dozens of therapeutic areas.
  • Process: our Standard Operating Procedures (SOPs) are not only market-validated but designed to conform to your specific requirements
  • Budget: our approach and technology helps us maximize leveragability and usability while embracing the obligations and constraints set forth when operating in regulated environments

Coupling these elements with the first-hand experience that our GRS team has gained over the years while partnering on an extremely wide-array of projects (from Investigational New Drug (IND) Labeling to Accelerated Centralised Procedures (CP) Registration) will without a doubt make for a very interesting conversation.

MedicalDevice_IconsMedical Devices

The Medical Device industry is well aware of the ever-increasing amount of content (including software, user manuals, instructions for use (IFU), labels, and more) that it needs to translate into an ever-increasing number of languages in order to market its products around the globe.

Despite the maturity of these multilingual requirements in certain markets (IVDD, MDD, etc.), the constant evolution of the highly regulated medical device landscape requires a sophisticated, rigorous yet flexible global approach to the translation process that is championed by our Global Regulatory Solutions (GRS) team.

Our GRS team is composed of thousands of global experts that stand out because of their in-depth knowledge of the medical device industry and years of direct multilingual labeling and packaging experience. Other highlights include:

  • Continuous Improvements: our focus is always on maximizing ROI for our customers, whether we are looking at cost, consistency, quality, turnaround, to name a few.
  • Quality Systems: our Lean Six Sigma program helps us advance our Quality Systems beyond the Standard Certifications
  • Innovative Technology: our cloud-based translation technology platform provides our Medical Device customers a single access point to their entire multilingual ecosystem

Whether your labeling requirements are straightforward and linear or whether they are broad and complex, our GRS team would be delighted to help you take full advantage of your multilingual capital.

 

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High-quality labeling and packaging

  • 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