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Kate Norton has over 20 years of Regulatory Affairs experience in the pharmaceutical industry. Her experience includes hands-on regulatory experience encompassing all stages of drug development including nonclinical and clinical (Phases 1-4) as well as regulatory support of commercialized products. She has expertise in developing and implementing regulatory and development strategies to support clinical, nonclinical and CMC regulatory filings for a variety of conventional and unique dosage forms, as well as active pharmaceutical ingredients.
Kate has been instrumental in coordinating, co-authoring and submitting INDs and international clinical trial applications and amendments as well leading marketing approval submissions in the EU, Australia, New Zealand and Canada. Additional critical regulatory activities include post-approval labeling and nonclinical, clinical and CMC variances, notifications, prior approval supplements, changes being effected supplements and annual reports for marketed products. She has also reviewed and submitted adverse experience safety reports, labeling and promotional materials and organized, conducted and led meetings and teleconferences with FDA, DEA and international regulatory bodies.
Additional skills include Quality Assurance and Management to include writing standard operating procedures for GLP, CGP and GMP requirements, establishing electronic and paper document control systems, and overseeing Pre-Approval Inspections as well as routine GMP and DEA inspections.
Kate has been consulting since 2011 with a focus on start-up companies needing guidance and hands on regulatory support during early-stage development through Phase 3.
Kate received her undergraduate degree in Biology at Indiana University in 1990 and her PhD in Developmental (Molecular) Biology at the University of Cincinnati Children’s Hospital in 1997.