Services do NOT include
Kindly contact the service provider for specific details.
May depend on the specific service requested ( 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, Access to information about the regulatory requirements, guidelines)
Sample Requirements - input of users
The user will have to provide the master study documents necessary for the opinion/advice/submission (e.g. Protocol, Informed consent, financial contracts, etc).
Timelines according to regulation.
Description of service
The EATRIS regulatory service is available to help guide you through this complex world, particularly for vaccines for which clear regulatory guidance may not be available to you. Early assessment of the potential regulatory requirements may prevent unnecessary project delays, reduce extra costs and most importantly prevent penalties resulting from non-adherence to legal requirements.
EATRIS range of services include:
Expert opinion and regulatory strategy planning
Pre-clinical and clinical development plan including TPP and IMPD
Informal scientific advice with selected national competent authorities, for highly complex projects
Access to 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 through the EATRIS Regulatory Database.