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Biologics & Medical Device Consulting Group

BioMDg is a unique consulting group comprised of a core team of Preclinical, Clinical, Regulatory and Marketing professionals closely aligned with a network of experts with proven track records in multiple areas of science, medicine and new technology marketing. We use a global comprehensive approach to bring products to market early.


Concept Evaluation

Pre-Clinical & Clinical Testing

Marketing Approvals

Clinical Development

Early Marketing Initiatives

Training


Contact BioMDg Today

377 Second Tee Dr.
Incline Village, NV 89451
info@biomdg.com

Our Core Competencies Include –

  • Regulatory Strategies and Submissions (incl. IDEs, INDs, PMAs, 510(k)s and European Submissions) and Clinical Trial Design, Submission, Oversight, and Analysis – including full CRO services, DSMB management, CEC management, IRB/IBC submissions, and submission of gene therapy studies to the Recombinant DNA Advisory Committee at NIH
  • Preclinical Study Design
  • Critical Literature Reviews
  • Scientific Business Plans – for Venture Capital Funding Due diligence and Valuation of New Technologies Hazard and Risk Analysis
  • Post Marketing Study Designs
  • White Papers
  • Continuing Education & Training