Regulatory Research

A significant advancement is the new European Platform for Regulatory Science Research launched in March 2025 by EMA/HMA, where key stakeholders from Academia, Industry and Competent Authorities come together to address gaps in scientific research, innovative technologies and regulatory practices. Possible roles for active participation of EMA in certain research projects have been also announced. For projects where this option is not applicable, the existing routes for interaction with EMA or national regulators are advised. At EU level, these include the SME office, Innovation Task Force, Scientific Advice and Protocol Assistance, PRIME and others according to applicability. 

Niconex does not support with benefit-risk assessments, clinical trials, study designs, PK/PD models, PIPs etc. As part of a research project, Niconex can locate the applicable procedures and channels of interaction and further develop the necessary plans for documentation and procedures to follow. Where applicable we can also submit requests and initiate the needful interactions for regulatory and scientific advice. 

Within research projects, applicable Intellectual Property Rights are studied to define first the types of protection that may apply. Throughout the project, relevant patents are studied to ensure any infringement is avoided. Monitoring new patents is a time-consuming practice but necessary from an early stage. Niconex employs professional tools to define relevant key words and terms, search EPO and WIPO databases, create lists of patents closely related to the technologies being developed as part of a research project, determine significant information on key players, patent valuations and actively monitor all the information throughout the project's duration. 

Niconex does not prepare or submit patent applications and at higher TRLs, professional legal advice and patentability analysis of the innovation will be required. Niconex supports with the preliminary IP research necessary as from early stages and in this manner, high legal costs are avoided at the very beginning of innovation projects.