MONICA ESCOBAR, Ph.D.
Int'l Biomedical Regulatory Sciences and Clinical Trials Programs
Part-time Assistant Professor
Int'l Biomedical Regulatory Sciences and Clinical Trials Programs
Dr. Escobar has a Ph.D. from the University of Florida in Analytical Chemistry and 25 years of pharmaceutical experience in Research and Development and Regulatory Affairs. At the start of her career, she worked in analytical research, developing analytical methods for new pharmaceutical products. She has been in Chemistry, Manufacturing, and Controls (CMC) in Regulatory Affairs for more than 17 years, supporting development candidates and marketed products. Dr. Escobar has worked with oral solid dosage forms, i.e. capsules and tablets; semi-solid dosage forms; transdermal patches; and liquid parenterals. She has experience filing the CMC sections of the Food and Drug Administration’s investigational new drug applications, new drug applications, abbreviated new drug applications, drug master files, as well as new drug application and European Medicines Agency dossiers. She will focus her teachings on CMC.
