The development of a new veterinary medicine requires navigating a structured yet often complex global regulatory environment, encompassing multiple submission types across regions. Given the wide range of species, production systems, and regulatory expectations involved, veterinary submissions demand strategic planning from early study design through to final dossier preparation. This article outlines the key steps and regulatory interactions that shape veterinary medicine development, including the use of scientific advice, harmonised guidelines, and consolidated or phased dossier formats. It also highlights the pivotal role of medical writers in ensuring clear scientific communication to support regulatory assessment, labelling negotiations, and the extensive post-approval submissions that make up much of a product’s lifecycle.