The Institute for Medical Research and Occupational Health (IMROH) is the second largest Croatian public research institution focused in biomedical and environmental research, toxicology, occupational health, chemistry, physics, and biology in environmental air research, health and safety, nanomaterial safety and has several national roles related to aspects of environmental pollution. IMROH fulfils its mission through basic and applied research to advance knowledge and innovation related to human health, monitoring general and occupational environment providing general, clinical and occupational health research and professional services by implementing its expertise in quality assurance and quality control.
In PHOENIX project, IMROH leads the establishment of the Regulatory Support Department that will offer regulatory support to end-users to eliminate “non-necessary” testing as well as to ensure “certainty” about regulatory compliance of nano-pharmaceuticals under development. The regulatory team will analyse the guidelines and legislation to develop PHOENIX Regulatory Roadmap that will help in determining any additional testing, studies or documents that might be required for target product prior to initiating clinical trials. Therefore, all relevant quality, safety and efficacy issues with regard to user product vs. gold standard and the overall regulatory acceptance of the nano-pharmaceuticals will be addressed, elaborated and evaluated.