EMMA UNGSTRUP - REGULATORY CONSULTANT & CEO
Emma launched her career in R&D, specializing in animal models, before moving into Nonclinical Toxicology and, for the past 2 decades, Global Regulatory Affairs. Her cross-disciplinary journey has equipped her with a comprehensive, end-to-end perspective on drug development—from early-stage research through to market authorization.
Emma partners with clients to craft comprehensive regulatory strategies that span the entire development lifecycle: from first-in-human trials and clinical development to marketing authorization applications (MAA) and commercial launch.
No matter where you are in your drug development journey—whether you’re a biotech forming your team, seeking funding, or preparing your first MAA submission—Emma can step in and leverage her deep regulatory and industry expertise to optimize your path forward.
Emma is an active member of Danish Biotek Association, Regulatory Affairs Professional Society, and is a mentee in the Women in Life Science Denmark mentoring program.
Emma has presented at Advanced Therapies conferences in the EU and USA.