“Chemistry, Manufacturing & Controls (CMC)” – one of the three pillars of pharmaceutical drug development and approval with all related areas surrounds my professional career. As a PhD pharmacist, I was engaged in the pharmaceutical industry in CMC development and international approval of innovative medicines for over 30 years. My background includes chemically synthesized and biologically manufactured active substances in solid, parenteral, inhalative, and topical dosage forms, as well as medical and combination products. I have always been inspired by the dynamic changes in the regulatory and scientific environment, their practical implementation in drug development, and the interaction with regulatory authorities. My focus has been on all relevant CMC activities, as well as regulatory and quality topics before and after approval (Product Lifecycle Management).
