Dr. Stephanie Krumholz is the founder and CEO of therainnova AG. With over 20 years of experience in the field of Regulatory Affairs, Dr. Krumholz is a seasoned expert in the industry. She holds a Dr. rer. medic thesis from the Department of Obstetrics and Gynaecology in Berlin, Germany and is a pharmacist by profession.
Dr. Krumholz specializes in leading and guiding biopharmaceutical companies in managing regulatory pathways in the EU and Switzerland, meeting and influencing health authority requirements, and increasing the value of a company's assets from a regulatory perspective. Her strong leadership, strategic thinking, and cross-functional teamwork skills have been honed through her experience working in both big pharma and small biotech companies, as well as consulting.
She has led Regulatory Affairs Projects from early development to filing marketing authorizations, new drug applications, and biologic drug applications in the EU, Switzerland, and US, across various therapeutic areas and products, including small molecules and biologics. Dr. Krumholz has also led health authority meetings in Europe, Switzerland, and globally, and has assisted companies in setting up their regulatory departments in Europe. Additionally, she has advised and submitted Scientific Advice Procedures, Acceleration Pathway submissions, Orphan Designations and Paediatric Plans in both Switzerland and Europe.
Dr. Krumholz successfully works in global partnerships and has supported projects such as Project Orbis and Access Consortium. She also has experience in issue management, handling due diligences, and worked in the M&A / venture capital field. Additionally, she spent 4 years living abroad in the US and has gained valuable experience in working with different cultures and customs, which have helped her to build strong relationships with people from all over the world.
Dr. Krumholz is dedicated to improving access to medicines for patients, using her skills and knowledge to make a real difference in people's lives.
