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    Bdra Consulting, Llc

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    Description

    • Regulatory SupportOur consulting services include:Regulatory strategies for Medical Devices, In vitro Diagnostics, orphan drugs or HDE and Combination product developmentAssistance in developing design controls including Design History, Device History and Device Master file Evaluation of Device classification providing detailed reportsIndication for use statements and identifying Predicate devicePremarket Notification Submissions (510(k)), Traditional, Abbreviated or SpecialRequest for designation (Combination Product or Orphan Drug) Pre-IDE/ Pre-IND and Pre-Pre-IND submissions and meeting supportIDE/IND application and meeting supportPreclinical Protocol planning and design (note biostatistical assistance would be required which is not included as a part of BDRA Consultings fees and would have to be paid by the Client)Quality Systems Regulation and manufacturing compliance assistanceRisk analysis and mitigation assistanceBusiness 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 processBusiness plan writing and development
    • location

      Headquarters:1 Clearwater Court , Damascus, Maryland, United States

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    • Bdra Consulting, Llc phone

      Phone Number: +1 301-922-7231

    • Bdra Consulting, Llc website

      Website: https://www.bdraconsulting.com

    • Bdra Consulting, Llc employees

      Employees:2

    • Bdra Consulting, Llc revenue

      Revenue:$0 - 1M

    • Bdra Consulting, Llc legal name

      Legal Name:Bdra Consulting, Llc

    • Bdra Consulting, Llc's Social Media

      Bdra Consulting, Llc linkedin
    • done Is this data correct?

    • |  NAICS Code: 561110  |

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    Frequently Asked Questions regarding Bdra Consulting, Llc

    • Where are Bdra Consulting, Llc's Headquarters?

      Bdra Consulting, Llc's Headquarters are in 1 Clearwater Court ,Damascus,Maryland,United States

    • What is Bdra Consulting, Llc's phone number?

      Bdra Consulting, Llc's phone number is +1 301-922-7231

    • What is Bdra Consulting, Llc's official website?

      Bdra Consulting, Llc's official website is https://www.bdraconsulting.com

    • What is Bdra Consulting, Llc's Revenue?

      Bdra Consulting, Llc's revenue is $0 - 1M

    • What is Bdra Consulting, Llc's NAICS code?

      Bdra Consulting, Llc's NAICS code is 561110

    • How many employees are working in Bdra Consulting, Llc

      Bdra Consulting, Llc has 2 employees

    • What is Bdra Consulting, Llc's Industry?

      Bdra Consulting, Llc is in the industry of Medical Devices

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