CTD: requirements for non-clinical/
clinical modules and eCTD readiness

Non-Clinical Consultant and Founder In early 2023 Alexandra Günzl founded Karyon Biopharma Consulting e.U. and supports clients as a non-clinical consultant in a wide range of issues related to non-clinical drug development. In her former position as Non-Clinical Consultant at MC Toxicology Consulting GmbH where she worked for more than 10 years, she contributed to the successful development of numerous drug candidates with a focus on biologics and ATMPs. She studied biotechnology with a focus on biomedicine and was trained in experimental cancer research during her PhD. Alexandra Günzl deepened her regulatory expertise through postgraduate training on "Regulatory Affairs of Biopharmaceuticals including ATMPs" (EUCRAF).

Pharmacist, MBA , Managing Director Team Leader Pharmakovigilanz & Team Leader Innovations After studying pharmacy, she worked as a regulatory affairs manager and took over the family business in 2019. She has more than 8 years experience in (WEU) submissions and regulatory strategy.
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Associate Director Medical Writing After her studies in human and molecular biology and research in cell biology, Sabrina Stöhr focussed on clinical research. For more than 10 years, she has been working as a medical writer on the preparation of clinical authorisation documents in various therapeutic areas. She deepened her expertise with a Master's degree in Drug Regulatory Affairs (DGRA).

Managing Director After studying biology at the University of Vienna, Kurt Eisinger worked as a project manager in product development at Octapharma. As a project manager at the biotech company igeneon, he came into contact with submission management software for the first time. He subsequently expanded his specialised knowledge as Head of Document Management. Since 2005, he has been working independently as a management consultant in the field of submission management. He creates electronic authorisation dossiers and also supports his clients in the area of regulatory affairs.