Global Regulatory Affairs

In a highly-regulated industry such as Life Science, the importance of having correctly translated documents cannot be underestimated to avoid possible refusals of drug registration or possible misuse by users.

We take our pharmaceutical translation services very seriously and are aware of the dire consequences of a poor or out-of-context translation. To ensure that all our translations reach maximum quality, we have established a system based on the European quality standard EN 15038:2006.

Our approach is to give you a single point of contact Project Manager that allows you access to our worldwide network of linguists and translation experts, giving focused attention to the right therapeutic area and emerging languages.  Thanks to this experienced network of partners, we can offer certified translations of any scale in virtually any language combination, covering a wide range of subject matters relating only to Life Sciences.

We view translations as an integrated activity within our scope of service and provided added value by having an in depth understanding of regulations and regulators expectations (both stylistic and technical).  

Some examples of documentation we can translate

  • Regulatory Documents
  • Packaging and Labelling
  • Patient Information Leaflets (PILs)
  • Summaries of Product Characteristics (SmPC)

Business Cases

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If you are interested in our service please contact us for more information.

Telephone+353 125 44033

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