Admirus Consulting

ADMIRUS has considerable global expertise in navigating both pre-clinical and clinical development and understand the requirements for entry-into-man studies, single and escalating dose Phase 1 studies and more advanced phase efficacy/safety studies. Navigating the regulatory terrain is a cornerstone of our proficiency. We have considerable first-hand experience dealing with the European Health Authorities (EMA), the US FDA and other major Health Authorities (China’s CDE, Japan’s PMDA, India’s DCGI, Australia’s TGA etc). We are adept at ensuring that clinical development plans align seamlessly with regulatory requirements. We understand what it takes to develop, register and bring products successfully to the market. Our expertise is based on our deep and broad understanding of the science and the clinical and regulatory environments. Combined, we have more than 50 years experience in Europe, the USA and Asia-Pacific focussing on bringing drug candidates along the complex and time-consuming development pathway to market. We have experience in a range of therapy areas, including rare diseases and understand what is needed to bridge globally-developed products to meet Asia-Pacific requirements (and vice versa). ADMIRUS has extensive experience in Medical Affairs, successfully launching multiple drugs in China and Australia and supporting commercial endeavours in most Asia-Pacific markets. We are familiar with the complex setting involving a highly regulated pharmaceutical sector and the different needs of all stakeholder groups, including patients, advocates, and healthcare professionals. Our collaborative approach with clinical trial physicians allows us to understand the essentials for building post-launch prescriber relationships. A key strength lies in our effective pre-launch strategies, ensuring commercial success in product launches. Contact us to see how we can accelerate bringing your products to market.