Maria A. Geigel has 45 years industrial experience, the last 30 exclusively in the pharmaceutical industry. Her expertise is Regulatory Affairs Chemistry, Manufacturing and Controls (CMC), Quality Assurance (QA), and Compliance. She held various positions in Regulatory Affairs at Syntex, with responsibility for both US and international filings and was Director, Technical Regulatory Affairs and Director, QA Stability Laboratory at Janssen Pharmaceutica, a Johnson & Johnson Company, before forming MAG Associates.
Maria Geigel has dealt with all aspects of CMC, from planning, through IND to NDA and post-approval supplements, as well as FDA inspections. She is proficient in dealing with a variety of dosage forms as well as active drug substance issues and working with pharmaceutical and chemical manufacturing facilities. She has prepared CMC sections of DMFs, INDs, NDAs and ANDAs; developed and implemented regulatory strategies for worldwide registrations; interacted with FDA and foreign regulatory agencies to accelerate worldwide approvals; interacted with pharmaceutical and bulk chemical manufacturing sites to assure preparation of approvable dossiers; established a new department to handle all CMC issues; trained and developed professional staff to handle complex regulatory issues and accelerate regulatory approvals; participated in cGMP and Pre-Approval Inspections in US and foreign sites; directed expansion of a stability laboratory; defined analytical laboratory QA systems and SOPs; evaluated the regulatory status of potential acquisitions; and participated in worldwide re-engineering efforts.
Maria Geigel teaches a course on Preparing the CMC Section for NDAs/INDs/CTDs (video introduction), and has organized and spoken at numerous courses and symposia. She has an M.S. in Organic Chemistry from the University of Colorado and an M.B.A. in Management from Golden Gate University. She is bilingual in English and Spanish.