Your single source for all Regulatory Labelling needs

We offer an attractive complete package for Regulatory Labelling – from coordination of all relevant processes (including communication with the respective national competent authorities) to the translation of your product information in all of the required 24 EU languages.

With a combined 60 years of expert knowledge in Regulatory Labelling, we will stand by your side to consult and support you with the following:
  • Strategic/regulatory advice during the entire product lifecycle in the EU procedure
  • Assistance with creating/optimising the English text
  • Timely management of the whole regulatory process between Day 0 and Day 235/Day+25
  • Lifeycycle management of your product information texts
Continuously delivering precise translations and proofreading of your English product information in all of the required 24 EU languages. We only use native linguists that are specialised and have demonstrated their knowledge and experience in the field of medicine and regulatory affairs.

More information


Our ServicePlus

  • Process expertise

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

Our Guarantee

✔ Your single source - complete package for Regulatory Labelling

✔ Only qualified technical translators, native in the target language

✔ Internal quality assurance

✔ Comprehensive non-disclosure agreements with customers and suppliers

✔ Certified processes according to DIN EN ISO 9001:2015

✔ Reliable delivery
Your contact
   
Christoph Buchfelder
Team Leader Global Regulatory Affairs
Unsere Qualitätsstandards sind durch die tiefe Spezialisierung und
fortwährende Prozessoptimierung auf einem außergewöhnlich hohen Niveau.