Our regulatory affairs and pharmaco-economics expert team will help you at any phase of the life cycle of the treatment intervention. From assessing which type of intervention it can be – drug, medical device or other – through setting translational and regulatory strategy, managing the entire regulatory part of projects, identifying critical product and project parameters up to the final stage of price set up. Our team consists of experienced professionals, and we continuously monitor global trends, publish the results of our research and look for new solutions to emerging issues. Just as regulatory expertise is the basis for the successful development of any medical product, pharmacoeconomics and health technology assessment are a key element for decision-making processes, including cost-effectiveness, value proposition, and therapeutic impact data. All this determines the availability of treatment for the patient.
Regulatory Strategy Development/ Management Plan
Real-World Data (RWD) Assessement
Comparative Effectiveness Research