Regulatory Translations

Compliance with international regulatory bodies is crucial for the success of products in the global marketplace, involving the production of content in multiple languages. Working with a translation agency that is familiar with local regulatory requirements is therefore crucial in order to produce accurate translated documents to meet regulatory approval.

Specialist Team

The Translation People have many years’ experience supplying regulatory translations to support the global operations of our clients in the medical sector. Our specialist medical translators have extensive experience of translating documents such as SmPCs, labelling and PiLs, using approved terminology and templates, to comply with the requirements of the EMA, FDA and other regulatory bodies.

Our specialist medical account managers will manage your project within our ISO 9001:2008 processes to ensure that your projects are delivered on time, within budget and up to regulatory and industry standards.

Document Types

Our expertise covers the following document types:

  • SmPCs
  • Labelling
  • PiL
  • SoPs
  • Validation Protocols

Translation Memory

Our Translation Memory tools store your preferred terminology and completed translations in a secure location, allowing our linguists to translate your content in line with your expectations. Furthermore, the technology allows processes to be streamlined for duplicate and similar content, reducing time to market and enabling costs savings to be passed on to you.

If you would like a quote for a regulatory translation project, please contact one of our Account Managers now.



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Whether you have a specific project you want to discuss, need a translation quote or simply want to discuss your requirements, do not hesitate to get in touch with us.

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