Maria A. Geigel is an independent consultant with MAG Associates, LLC. Her primary area of expertise is in regulatory affairs for Chemistry, Manufacturing and Controls (CMC). This experience covers synthetic active ingredients and all types of dosage forms.
With over thirty years of industry experience, she has prepared CMC sections of DMFs, INDs, NDAs, ANDAs and European Community dossiers – the most recent of these in CTD format. She has also developed regulatory strategies for worldwide registrations; assisted companies with complex regulatory/compliance issues and interacted with chemical and pharmaceutical manufacturing facilities to assure preparation of approvable submissions.
Prior to consulting, Ms. Geigel held various positions in Regulatory Affairs at Syntex (now Roche) and was Director of Technical Regulatory Affairs and Laboratory QA at Janssen Pharmaceutica. In addition to her CMC experience; Ms. Geigel is also versed in Quality Assurance and has evaluated manufacturing and analytical facilities, defined Standard Operating Procedures (SOP), prepared facilities for inspection, provided GMP training and responded to numerous observations from the FDA.
Ms. Geigel – bilingual in English and Spanish – received her M.S. in Organic Chemistry from the University of Colorado and her M.B.A. in Management from Golden Gate University.