Product information texts are central to a marketing authorisation dossier and are subject to a multitude of regulatory requirements. They are among the few documents that are publicly accessible and thus have an external impact. Moreover, the EU's centralised marketing authorisation procedure requires them to be made available in all 25 EU/EEA languages.

We offer you an all-in-one labelling service package that consists of the following:

  • Strategic/regulatory advice during the entire product lifecycle in the EU procedure (e.g. new MAA, variations, renewals, line extensions)
  • Assistance with creating/optimising the English text (e.g. consistency with the CCDS/CCSI, options for combining product strengths, optimisation of packageleaflet readability)
  • Translations, updates and revisions in all required languages by Regulatory Affairs specialists and native speakers with medical expertise
  • Timely management of the whole regulatory process between Day 0 and Day235/Day+25:
    • Coordination of all activities involved in creating the language versions
    • Coordination of the review of all language versions by the client's affiliates
    • Coordination of all interactions with the 24 national competent authorities (NCAs) as part of the Linguistic Review process, including Eudralink submissions
  • Lifecycle management of your product information texts