Regulatory Labelling

We can help you with the process of authorizing
your medicinal products.

Everything under one roof

Our complete package for your regulatory labelling at the European level


Are you looking for a language service provider for your regulatory labelling needs that …

  • assists you even with creating your source texts,
  • offers you expert advice as part of the regulatory process
  • handles all communications with the authorities,
  • is familiar with the tight regulatory timelines and the requirements of the respective national authorities,
  • also implements changes flexibly at short notice, and
  • translates your product information into all of the languages that you need?


Then our comprehensive regulatory labeling service is exactly right

From application to authorization

We take care of all regulatory labelling matters.


The product information is the central document in an authorization dossier. It is subject to a multitude of regulatory requirements, and it is one of the few documents that is publicly accessible. It therefore forms an important part of how your product is perceived externally. In the centralized EU authorization procedure, the texts must also be made available in all 24 EU/EEA languages.

Our expertise for your project

Together with our long-term partner in the field of regulatory labelling, we will guide you through all of the process steps. We will help you to create your source texts, produce professional specialist translations of your product information, and communicate on your behalf with the competent authorities.
 

Our complete service package for regulatory labeling includes:

  • strategic, regulatory advice during the entire product cycle of the European authorization procedure (e.g., new MAA, variations, renewals, and line extensions)
  • assistance with the creation and optimization of English-language texts (e.g., ensuring consistency with CCDS/CCSI, possible combinations of product strengths, and optimization of package leaflet readability
  • professional translations of your product information and revision by our regulatory affairs specialists and mother-tongue specialist translators in all required languages

    timely management of the entire regulatory process between day 0 and day 235/day +25, including:

    • coordination of all activities related to the creation of the language versions
    • coordination of the checking of all language versions by the customer’s in-country representatives, upon request
    • coordination of all interactions with the 24 national competent authorities (NCAs) as part of the linguistic review process, including the Eudralink submissions upon request
    • lifecycle management of your product information texts

    A well thought-out service from beginning to end

    in the area of regulatory labelling

      

    • You can rely on us.
      Your project manager is your personal contact. They will provide you with expert advice and guide you through the entire labeling process.
    • mt-g's complete service package
      We bring together our regulatory labelling expertise and our many years of experience in the professional translation of labelling documents.
    • Our reliable time management
      We know how important it is to comply with deadlines when having your medicinal products authorized. That is why we always keep an eye on all timelines for the punctual submission of your documents.
    • Convincing process expertise
      Our project managers are well acquainted with all requirements of the national and European regulatory authorities.
    • Two reliable partners committed to your success
      We have been conducting regulatory labelling projects together with a partner company for many years. Together, we can draw on more than 60 years of expert knowledge. Therefore, we are supremely capable of implementing your project, too.

    The final 300 days in a centralized authorization procedure

    and the all-in-one solution for your product information

     

     

    The final 300 days in a centralized authorization procedure

    and the all-in-one solution for your product information

     

     

    Contact us

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