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

Translation and validation of labels for investigational medicinal products (study drugs) taking into account the standard terminology
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Label check for the investigational medicinal product labels for each country where study sites are located

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. However, what is known as a label check has to be performed for every language, and its scope can vary depending on the country-specific regulations for each language or country.

Thanks to their comprehensive know-how for all language processes related to the marketing authorisation process and clinical trials, mpü has built a wide 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 checks

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 preparation 
• Investigated therapeutic indication
• Synopsis of the clinical trial (which determines the preparation type and 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 force in the respective country or region.

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