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 start up companies with regard to:
Identification of funding agencies and Request For Appilcations (RFA)
SBIR Grant assistance Technical and NIH SBIR submission process
Business plan writing and development

Company’s Keywords:

rfd, regulatory affairs, sbir, business development, 510, regulatory compliance