Shree Rac

Managing Partner at BDRA Consulting, LLC - Damascus, Maryland, United States

Shree Rac's Colleagues at BDRA Consulting, LLC
Shree Rac's Contact Details
HQ
Location
Damascus,Maryland,United States
Company
BDRA Consulting, LLC
Shree Rac's Company Details
BDRA Consulting, LLC logo, BDRA Consulting, LLC contact details

BDRA Consulting, LLC

Damascus, Maryland, United States • 1 Employees
Medical Devices

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

Details about BDRA Consulting, LLC
Frequently Asked Questions about Shree Rac
Shree Rac currently works for BDRA Consulting, LLC.
Shree Rac's role at BDRA Consulting, LLC is Managing Partner.
Shree Rac's email address is ***@. To view Shree Rac's full email address, please signup to ConnectPlex.
Shree Rac works in the Medical Devices industry.
Shree Rac's colleagues at BDRA Consulting, LLC are and others.
Shree Rac's phone number is
See more information about Shree Rac