EU AR and PRRC services Asphalion

ASPHALION, S.L

Barcelona, Spain

ASPHALION is an international Scientific, Safety and Regulatory Affairs consultancy company with offices in Barcelona, Madrid, Pamplona, Munich and London. Increased complexity in the Medical Devices regulatory landscape is generating greater challenges that need to be addressed in order to maintain a competitive position in the market. Asphalion’s solutions for Medical Devices cover a full range of technological segments, such as: Implants, Wound-care, Wearables, IVDs, Software as Medical Device, Substance based and Drug Device Combinations, among others. Starting from a proof of concept, throughout the design & development process, product approvals and maintenance of the device in the market, Asphalion can provide you with full Regulatory and Quality Management System (QMS) support for a time to market optimisation by minimising regulatory setbacks since the very beginning. Our team of MedTech consultants, integrated together with our pharmaceutical and scientific consultancy services, will keep you ahead of market challenges and will help you meet all regulatory and quality requirements.