ADVENA USA

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... 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 review We can provide comprehensive, project oriented, regulatory affairs consulting services when you need them most... Advena USA has over 12 years experience in domestic and foreign regulatory affairs for medical devices. We have assisted small, medium and large foreign and domestic companies in the successful completion of..

Primary location: Dallas United States