The Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU) intends to use a framework service contract to provide a central support system that will capitalise on project results generated by increasing or securing their impact and sustainability through adoption into regulatory agency guidelines or standard practice.

The objective of the initiative is to ensure that the key results generated by IMI projects are acceptable in a research and development (R&D) context (non-clinical or clinical studies), and are therefore implemented in the regulatory practices.

The results include novel biomarkers, endpoints, outcomes, tools/methodologies, recommendations that would support development of regulatory guidance documents. This may cover different disease areas or axes of research as per the IMI Strategic Research Agenda.

The contractor will be expected to:

— identify and prioritise the relevant project results;

— identify information/data gaps that need to be addressed to complete the submission;

— support preparation of files to be submitted to the EMA and FDA, and preliminary engagement with the agencies;

— implement process, quality criteria to be replicated across all projects, etc. to secure efficiency, consistency and quality.