I have worked in Chemistry, Manufacturing, and Controls (CMC) in Regulatory Affairs for more than 17 years.
Part-Time Assistant Professor
I have 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 my career, I worked in analytical research, developing analytical methods for new pharmaceutical products. I have worked in Chemistry, Manufacturing, and Controls (CMC) in Regulatory Affairs for more than 17 years, supporting development candidates and marketing products. I have worked with oral solid dosage forms, i.e. capsules and tablets; semi-solid dosage forms; transdermal patches; and liquid parenterals. My experience includes 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. I will focus her teachings on CMC.
Learn more about Monica Escobar