Is Goldbug Right For You?
Goldbug Strategies can provide the expertise you need in the current evolving regulatory and reimbursement landscape. We can also provide you the tools to transform objectives to results. Our team leaders are available to understand your objectives and explain our expertise, services, and proven record of success.
Goldbug’s consultants hold unique scientific, legal, government, business, and clinical backgrounds and can provide you the right mix of expertise. Goldbug provides recognized experts who offer strategic analysis and advice to executive teams, regulatory and clinical laboratory professionals, boards of directors, bankers, and everyone on your team needing to make decisions with confidence.
A client’s challenges and opportunities can be as dynamic as the regulatory policy landscape. Our due diligence, strategic advice, and related services support the breadth of the business of molecular science and digital technologies including:
- Biomarker test development
- Companion Diagnostics & co-developed therapeutics
- Cancer vaccine development
- Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) regulatory oversight and compliance
- Software as a Medical Device (SaMD)
- Laboratory Developed Tests (LDTs)
- FDA compliance & enforcement
- In vitro diagnostic (IVD) instruments
- Software & reagents
- Next Generation Sequencing (NGS) technologies
- Reimbursement policies for IVDs and LDTs
- Landscape analysis & due diligence
- Potentially or partially regulated products or services including LDTs
- Wellness apps
- Over-the-Counter (OTC) & Direct-to-Consumer (DTC) products/advertising
- Pipeline analysis & annotation technologies
- Clinical Decision Support (CDS) software
- Mobile medical apps (MMAs)
- Other types of digital health technologies
Due diligence is the foundation of the work we do. At Goldbug Strategies, we know how important it is to incorporate the latest insight on FDA and CMS into your strategy to mitigate compliance risk and capture return on investment. Our unique expertise enables us to identify and evaluate your options. Our expert recommendations support the best approach for where your company is today and where you hope to be tomorrow.
Many pharmaceutical and biotechnology companies are discovering the need to understand the regulatory and payment-model landscape associated with diagnostics. Companies and investors ready to develop targeted therapeutics for the personalized or precision medicine market, are encountering new and unexpected roadblocks and regulatory complexity. The specialized knowledge our consultants possess allows us to tailor unique recommendations for clients.
Goldbug realizes client risk tolerance can vary. Our consultants have a proven track record of creating new regulatory opportunities, minimizing the impact of unanticipated enforcement actions, managing risk, and driving success for companies whose products have been caught between regulatory systems.
Our clients range from established industry leaders to small funded start-ups. Many, regardless of size, face unfamiliar compliance regulations that may seem ill-suited to advancing innovative technologies. This uncertainty may make the path forward appear nonexistent. However, Goldbug Strategies pulls from its extensive experience and earned credibility with policymakers to realize possibilities. Our comprehensive solutions enable your team to forge new paths to overcome potentially costly regulatory roadblocks.
next. generation. advisors.
Goldbug Strategies LLC
510 Diamondback Drive, Suite 570
Gaithersburg, Maryland 20878