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… Our experienced advisory team will accelerate the go-to-market strategy for entrepreneurs and investors in biomedical, molecular diagnostic & life science ventures. We can reduce the time-to-market, reduce the risk and optimize the return on investment.


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Regulatory

  • CMS guidelines
  • FDA regulations guidance  
  • IVD, ASR, LDT
  • product claims
  • labeling
  • 510(k) vs.PMA applications
  • CLIA

A sound regulatory strategy provides a foundation for successful healthcare innovation. This is particularly relevant for diagnostics companies that develop sophisticated diagnostics products that face increased regulatory oversight of ASRs & IVDMIAs, or that deal with evolving regulation of home-brew tests & CLIA labs.