European Bridging Projects

The objective of our services is to plan bridging studies for your authorised projects so that you achieve substantial savings in costs. Our services include the following activities:

  • Analysis of your product portfolio for bridging-relevant similarity in your product information. This is useful above all when the same products have various national authorisations in different countries. Apart from the analysis of the QRD templates used, this checking also includes an assessment of the content and the linguistic style. The checking will also be performed across language barriers and will include an assessment of the readability of your product information.

  • Revision of your European SmPCs, PLs and label information, e.g. on the basis of CCDS or CSP updates the course of a Europe-wide harmonisation of information. This is the ideal precondition for an extensive and cost-saving bridging strategy.

  • Planning of a cost-effective European bridging strategy on the basis of the results of the analyses. This will enable you to obtain the maximum benefit from the possibility of bridging.

  • Creation/revision and translation of all your product information in order to achieve the maximum possible harmonisation of the contents and transferability of the test results. This will increase the possibilities for bridging studies and decrease the number of readability tests required for your portfolio.

  • Evaluation of existing readability tests for their usability as reference study for further similar products (as “parent” PL) in a bridging study. On the basis of our experience with queries from regulatory authorities, we will check the probability of the study reports being accepted by various authorities (e.g. BfArM, PEI, MHRA, etc.). Furthermore, we will help your to recognise risks and to define appropriate studies as reference tests.

  • Coordination of your readability user tests.

  • Preparation of necessary variations.

  • Layout and desktop publishing services, including multilingual sets.

Our specialists are at your disposal for detailed consultation and potential planning. Please contact us if you have questions about the possibilities for a European bridging strategy.