Concepción "Coki" Cruz, MS
TCG Consultant
Coki Cruz, MS, is a consultant at Toscano Consulting Group, Inc. (TCG) with over 35 years of combined experience in the US-FDA and pharmaceutical industry.
Throughout his tenure with the US-FDA, Mr. Cruz performed and supervised regulatory analysts, investigators, and compliance officers’ operations, conducting a diverse array of assessments in the biopharmaceutical and pharmaceutical arena.
Mr. Cruz commenced his career at Bristol Myers, followed by stops at Sterling Drugs, and Rhone-Poulenc Rorer in his native Puerto Rico, gaining expertise in small volume parenteral, active pharmaceutical ingredients, and solid oral dosage manufacturing operations, respectively. His extensive background encompasses laboratory, process validation, equipment qualification, and overall process enhancements, while his US-FDA adds regulatory biotech and pharmaceutical products inspection experiences, as well as inspection report reviews.
As a consultant, Mr. Cruz assists pharmaceutical and biopharmaceutical firms providing specialized knowledge and strategies for compliance with current regulations.
Mr. Cruz holds a master’s degree in regulatory affairs and quality assurance from Temple University, School of Pharmacy program, and a bachelor’s degree from the University of the Sacred Heart.