Addressing regulatory issues is an integral part of bio medicinal development, and their importance will only continue to increase for the foreseeable future. Regulatory services help guide you through this complex world, especially for complex and hybrid products for which clear regulatory guidance may not be available. Early assessment of the potential requirements may prevent unnecessary project delays, reduce extra costs and most importantly prevent penalties resulting from non-adherence to legal requirements.

EATRIS regulatory service and support centre

Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of products:

Our range of services include:

  • Expert opinion
  • Orphan Drug Designation and Scientific Advice application at the EMA
  • Pre-clinical and clinical plan development
  • Informal scientific advice with selected national competent authorities, for highly complex projects

EATRIS also developed a Regulatory Database, freely accessible, that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation. To request access to this database, please fill in this form.