Regulatory Affairs

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Regulatory Affairs

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Regulatory Affairs

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Correct vertaalde documentatie is essentieel in de registratieprocedure van een geneesmiddel. Deze procedure geschiedt volgens de regelgeving van het European Medicines Agency EMA (https://ec.europa.eu/health/documents/eudralex_en) dat deelnemende Europese landen vertegenwoordigt bij de introductie en beoordeling van nieuwe geneesmiddelen. We vertalen verschillende soorten documenten die in deze procedure beoordeeld worden, waaronder:

 

  • PILs (Patient Information Leaflet)
  • SmPCs (Summary of Product Characteristics)
  • Verpakkingsteksten
  • Marketingteksten
  • Groothandelsvergunningen
  • Fabrikantvergunningen

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Contact

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Harald translations for all EU-languages is open from Monday till Friday 9.00 – 17.00 GMT+1

You can reach us at the following numbers:
Phone: +31(0)317 620202
Fax: +31(0)317 620787
E-mail: harald@harald.nl
For urgent matters please contact +31(0)655885758.
We will be glad to support you!

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