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Country-specific label check for translations of labels for your investigational medicinal products

Translation of labels for investigational medicinal products taking into account Standard Terms
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Label check for investigational medicinal products per study site country


Optimal use of resources for the highest quality

 

When translating labels for investigational medicinal products for clinical trials, the time and effort needed for the translation itself is relatively small.

                   

But a so-called label check has to be performed for every language, and – depending on the country-specific regulations for each language or country – what this involves can vary.

Thanks to their wide-ranging expertise in all language processes related to the marketing authorisation process and clinical trials, mpü + orangeglobal have built an extensive network of specialists for this specialised service.

We have the ability to respond quickly to your specific requirements and we can develop these customised workflows with all of the steps for you. So your trial can start on time.

 


Label check

 

The country-specific label check for the investigational medicinal product checks and adapts the translation of the master label according to the following criteria:

  • Exact content of the master label
  • Composition of the product
  • Investigated therapeutic indication
  • Synopsis of the study (that determines the product type and its usage conditions)
  • Language and country of the study sites to ensure the correct adaptation of the label content and thus compliance with the regulations in effect in this region.

Using our specialised translation and language solutions, we successfully support globally active companies and CROs with all of their needs related to clinical trials.

Contact us – we would be happy to advise you in detail and help you with all of the workflows and technical options that can make your study conduct more efficient.