Regulation

Goldbug Strategies provides analysis, counsel, and strategic approaches for FDA regulated medical products including Laboratory Developed Tests (LDTs), devices, biologics, in vitro diagnostics, laboratory test reagents, components and instrumentation labeled Research Use Only (RUO) or Investigational Use Only (IUO), as well as stand-alone software/mobile applications and other products for which FDA may assert pre-market regulatory oversight or post-market enforcement under Draft Guidance.

Specific services include:

  • Compliance review and response
  • Regulatory pathways
  • FDA Informational and Pre-Submission meeting strategies and support
  • 510(k) and PMA submissions
  • Government engagement and advocacy
  • Promotion and advertising review and compliance strategies
  • External communications review
  • Regulatory risk assessment and risk minimization strategies
  • Business strategy and analysis for commercializing innovative diagnostic and biomedical products
  • Regulatory and competitive landscape and analysis
  • Response letters and comments to the FDA Docket
  • Business analysis and strategies
  • FDA consultations
  • Executive updates and presentations
  • Development of strategic partnerships and 3rd party validators
  • Patient and provider group engagement strategies

next. generation. advisors.

Goldbug Strategies LLC
510 Diamondback Drive,  Suite 570
Gaithersburg, Maryland 20878
+1 (301) 355-2660

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