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Services / Regulatory Translation

Regulatory Translation Services

Morningside offers comprehensive regulatory translation solutions to help simplify the international compliance process and ensure accurate, on-time submissions. Clients rely on our regulatory expertise to deliver translations that are linguistically accurate and comply with all local and cultural requirements. We have over 20 years of experience helping global drug & device companies overcome regulatory hurdles, preparing their documentation for governing bodies around the world including the FDA, EMA, CFDA, SFDA, and PMDA.

Regulatory Documents We Translate Include:

  • Instructions for Use (IFUs)
  • Labeling
  • Package Information Leaflets (PILs)
  • Dossiers
  • Summary of Product Characteristics (SmPC)
  • Investigator's Brochures (IBs)
  • Validation Documents
  • Chemistry, Manufacturing & Control Documentation (CMC)

THE MORNINGSIDE ADVANTAGE

We Are Compliance Experts

In the ever-changing regulatory landscape, Morningside’s LS Team has subject matter expertise in a range of medical fields and in-depth knowledge of international regulatory requirements. Whether it’s labeling, CE marking, 510(k) submissions or the latest MDR revisions, Morningside’s life science specialists have the knowledge and expertise to help you obtain regulatory approval in critical markets around the globe.

An Unwavering Committment to Quality

Our subject matter expertise is just part of our unwavering commitment to quality. Our quality processes span every stage of the product lifecycle, from patent to post-market, with ISO 13485, 17100 and 9001-backed controls. Our linguists are rigorously vetted and have in-depth knowledge of terminology and nomenclature, which helps minimize non-conformances and ensure accurate translations.

Our Technology Enables

Morningside employs industry-leading technologies to lower costs, improve quality, and enhance the customer experience. Translation memory (TM) tools, for example,  leverage previous translation projects to speed up delivery, ensure consistency and lower costs. We also make it easy for you to manage your projects through our secure client platform, where you can get quotes, submit new projects, and download completed translations at your convenience.