Regulatory Affairs Professionals In Early Clinical Trials

This paper suggests new strategies in the duties of Regulatory Affairs Professionals (RAPs) inside current trends of research and development of new drugs, that is distinguished by many innovative targets and drugs candidates, overlaps basic research and optimization stages with early clinical trials, alliances between universities and private sector with pharmaceutical industries and revolutionary guidelines from regulatory agencies. From the analysis of bibliographic review is identified gaps where Regulatory Affairs Professionals could contribute to improve data to making decision, quality of submission and possibilities of clinical trials success. Keywords: Regulatory Affairs professionals (RAP); Early clinical trials; Good review practices