Anja Holm, DVM
EU Regulatory Affairs
My Story
Dr. Anja Holm (DVM) has a background in veterinary practice, followed by 18 years in the Danish Medicines Regulatory Authority, including 6 years as Chair of the Committee for Veterinary Medicines (CVMP) in the European Medicines Agency (EMA). Since 2016, she is a consultant for the Animal Health industry in development and licensing of new veterinary medicines with a special focus on EU veterinary medicines legislation and opportunities. From 2016 until acquisition in 2020, she was also the CEO of a biotech start-up.
Anja provides deep insight into EMA procedures and decision-making, VICH-compliant study protocols, regulatory requirements for safety and efficacy of pharmaceuticals and biologicals, and for MRL/residues. She can assist you with development plans, sparring on dossier content for EU, expert reports, company trainings, referrals, Limited Market products, etc.