Prof. Serafim Guimarães is a dual board-certified specialist in Nephrology and Clinical Pharmacology, also Academic Associate Professor, with over 20 years in clinical research. Serving as Principal Investigator (PI) in over 90 Phase I trials, he specializes in overseeing complex bioequivalence (BE) and special population studies, notably renal impairment trials including hemodialysis cohorts. His high standards for quality are proven by the research projects he has overseen collecting multiple No Action Indicated (NAI) classifications from the US FDA.