Advena USA
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Medical Device Regulatory Affairs Consulting


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.  
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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.
US Agents and Regulatory Consultants ADVENA USA