Global Regulatory Solutions

Meet all regulatory standards in all markets to get medical and health care products approved faster while meeting market expectations internationally.

Multilingual regulatory documentation requirements with flawless translation and localization

Protect your new product investment and patient health with Global Regulatory Services from Lionbridge Life Sciences. Our dedicated in-market teams combine language expertise, regulatory insights, enabling technologies and exceptional project management to ensure that every aspect of your multilingual documentation is approval-ready. From clinical trials, packaging and labels, to product registrations and marketing content, we deliver flawless language solutions and translation services that ensure compliance and effective communication in every target market.

Lionbridge Life Sciences expert teams deliver comprehensive Global Regulatory Solutions for clinical trial, approval and registration, packaging and labeling, pharmacovigilance & safety reporting, education and marketing communication and documentation, with:

  • Multilingual regulatory compliance services for translation, writing, proofreading, DTP and independent SME review
  • Graphic engineers and QA services for Member State/Local Health Authority formatting compliance
  • Certification and validation program (external audit)
  • PIL user testing
  • Education and training
  • Technology as a managed service, including Multilingual Asset Management (translation memories, glossaries, style guides, artwork), for administrative time and effort savings
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How to increase efficiencies and decrease costs with a centralization model

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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

Pharmacovigilance

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Contact us to learn more

Learn how Lionbridge Life Sciences provides the highest quality translation for all phases of global content lifecycle.

Contact us

Lionbridge Technologies
1050 Winter Street
Suite 2300
Waltham, MA 02451

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Lionbridge’s professional translation services enable more than 800 world-leading brands to increase international market share and effectively engage their customers in local markets worldwide.