RegulatoryEdge

RegulatoryEdge provides Regulatory Affairs consulting services to pharmaceutical companies worldwide as well as Business Development, Drug Safety and Medical Information services for Medicines, Medical Devices and Cosmetics. We are passionate advocates of the power of drugs to transform lives. Key area of expertise include regulatory affairs consulting in area of regulatory development, submissions and commercialisation of products, critical review and analysis of manufacturing, toxicology and clinical data, and negotiation of win-win outcomes with regulatory authorities. Other expertise include medical affairs and pharmacovigilance as well as skills such as project management, and leadership of cross functional initiatives with global scope to ultimately achieve greater business efficiencies and maximise commercial opportunities. We believe everyone everywhere should have access to medicines that are safe and effective. Some of the specialised projects we are currently assisting our clients with are:. We offer unique Regulatory Affairs coaching to selected clients who may be under pressure to achieve commercial goals with their existing resources, or are looking for innovative approach to Regulatory Affairs management.