Expertise

Goldbug Strategies has decades of experience advising clients in the areas of:

Goldbug is committed to helping biomedical and digital technology companies advance innovative products by managing challenging regulatory, competitive, and reimbursement environment. Our consultants have worked extensively across industries in the personalized/precision medicine space and we possess deep expertise in the areas of Laboratory Developed Tests (LDTs), in vitro diagnostic products (IVD), targeted therapeutics, and companion diagnostics.

We deliver the expertise and strategic insight needed to enable clients in molecular science and innovative digital health technologies to achieve their business objectives and optimize success.

Areas of Expertise:

  • Food & Drug Administration (FDA) regulation & policy
  • Molecular diagnostics
  • Co-developed biomarker/assays for targeted therapeutics
  • Companion diagnostics & therapeutics
  • Next Generation Sequencers (NGS)
  • Research Use Only (RUO) compliance
  • Analyte Specific Reagent (ASR) compliance
  • Clinical Decision Support (CDS) software
  • Stand-alone software
  • Software as a Medical Device (SaMD)
  • Direct-to-Consumer (DTC) policy & compliance
  • Clinical Laboratory Improvement Amendments (CLIA)
  • Molecular diagnostic reimbursement policy & strategy

Key LDT/IVD Specialty Expertise:

  • Due diligence/strategy assessment
  • Development, manufacturing & marketing strategy
  • FDA compliance inquiries/warning letters
  • Regulatory risk assessment
  • Board meeting/executive team support
  • Advertising & promotional review
  • Executive level regulatory insight & training
  • Quality systems & application of ISO, CLIA, FDA, QSR
  • Regulatory & clinical/scientific validation gap analysis
  • Quality systems Regulations gap analysis & Quality Assurance
  • CLIA, CAP, ISO & FDA gap analysis
  • Technology/digital health
  • Nutrition & wellness
  • Direct-to-Consumer advertising
  • Regulatory rescue strategy for IVD products
  • Federal legislative analysis & lobbying coordination
  • Coding, coverage & reimbursement risk assessment
  • Managed markets analysis & strategy
  • Executive level reimbursement policy insight & training

next. generation. advisors.

Goldbug Strategies LLC
7361 Calhoun Place, Suite 580
Rockville, Maryland 20855
+1 (301) 355-2660

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