Regulatory Research

The European Platform for Regulatory Science Research is a significant advancement 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. 

While closely following EU policies and strategies, including the new Pharma package, EU Biotech Act, EU AI Act, the Life Sciences strategy, One Health approach and Farm-to-Fork along with other important advances, Niconex as part of a research project can locate the applicable procedures and channels of interaction and further develop the necessary plans for documentation and procedures to follow. Where applicable requests can be also submitted to initiate needful interactions for regulatory and scientific advice. 

Within research projects, applicable Intellectual Property Rights are studied to first define 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 the European Patent Office (EPO) and World Intellectual Property Organisation (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 the updated information throughout the project's duration. 

Niconex does not prepare or submit patent applications and especially at higher Technology Readiness Levels (TRLs), professional legal advice and patentability analysis of the innovation is advisable. Niconex supports with the preliminary IP research which is necessary as from early stages to align with parallel technical research and development and in this manner, high legal costs are avoided at the early stages of innovation projects.