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Regulatory Labelling Service

Two strong partners to your success

To be able to provide you with an attractive, all-in-one regulatory labelling service package, we have evolved our long-standing collaboration into a proficient partnership.

With over 60 years of pooled expertise in regulatory labelling, we will be there for you every step of the way with guidance and action, and we can assist you with all labelling matters involved in both the new authorisation of a medicinal product and lifecycle management.

Your needs and wishes are the guiding principles that drive what we do. We would like to demonstrate to you that the best decision you can make is to choose a strong partner and that we are worthy of your trust because ...

... the product information is the business card of your medicinal product.

Regulatory Labelling
From application to authorisation

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

The last 300 days of a centralised MAA ...

Our ServicePlus
For your authorisation-related documents

Dedicated contact person

As a client, you will have direct access to a dedicated, specialist contact person at all times.

All-in-one package

We can offer you an all-in-one package that brings together regulatory labelling expertise with many years of experience with medical translations of labelling documents.

Reliability

We will never lose sight of your deadlines for timely submissions. You can rely 100% on our adherence to your timeframes.

Process expertise

Our team is fully acquainted with all the requirements of national and European authorisation authorities.

Have we captured your interest?

Good! It's now time for us to get to know each other. Please complete our contact form and send it to us. Our regulatory labelling specialists will then get back in contact with you shortly.