Donawa Lifescience

Donawa Lifescience, headquartered in Rome, Italy, is a leader in providing US and European regulatory, quality system and clinical services to life science companies. Our firm is a full service CRO, manages medical device and IVD device clinical studies throughout Europe and the US; provides US Agent services and European Authorized Representative services; through a sister company, provides United Kingdom Responsible Person services; and, also assists companies with meeting Canadian medical device requirements.

Company’s Keywords:

eu, us medical device, ivd clinical study management, fda device regulatory submissions, fda quality system compliance, ce marking technical file preparation, us ivd medical device services, us, eu combination product strategy & compliance