Regulatory requirements for product information in the EU (advice on compliance)

Our services include the creation of pharmaceutical product information and its localisation for the various registration procedures and Member States of the EU. We start with the localisation of CCDS (company core datasheet) documents for the European market, coordinate the creation of English core SmPCs, core PLs and labelling documents, coordinate the respective translations and, on request, also the submissions to the national authorities. Once your marketing authorisation has been received, we manage your documentation over the whole lifecycle.

Frequent topics for consultation included, for example, the following:

  • Readability compliance of the English core PL up to national authorisation
  • Implementation and checking of terminology specifications (e.g. EDQM and MedDRA)
  • Incorporation of quality assurance control and correction methods in the text creation and translation process

Talk to us. There is a solution for every problem and we will be happy to help you find it.
You can reach on the following number: +49 (0) 731 / 98 588-540