Bdra Consulting, LLC

regulatory support our consulting services include: regulatory strategies for medical devices, in vitro diagnostics, orphan drugs or hde and combination product development assistance in developing design controls including design history, device history and device master file evaluation of device classification providing detailed reports indication for use statements and identifying predicate device premarket notification submissions (510(k)), traditional, abbreviated or special request for designation (combination product or orphan drug) pre-ide/ pre-ind and pre-pre-ind submissions and meeting support ide/ind application and meeting support preclinical protocol planning and design (note biostatistical assistance would be required which is not included as a part of bdra consulting’s fees and would have to be paid by the client) quality systems regulation and manufacturing compliance assistance risk analysis and mitigation assistance business development we are experienced in assisting