At Advena USA we understand how complex regulatory compliance requirements can be. Our experts can assist your company with:•Document control solutions•Establishment registration and product listing•FDA 510(k) Pre-market Submissions•EU Technical Files•International product registration dossiers•Preparation and follow-up to FDA inspections•Regulatory compliance training•Responses to recall, deficiency and warning letters•Short-term regulatory staffing•Technical writing and label reviewWe can provide comprehensive, project oriented, regulatory affairs consulting services when you need them most.
Our goal is to provide cost-effective, efficient medical device regulatory affairs consulting services that are tailored to meet the unique needs of our customers.