Strategy Development

Effective strategy is the backbone of product commercialization and plays an essential role in future market success. Goldbug Strategies is one of the industry’s leading FDA regulatory consulting firms renowned for its novel strategies with innovative, first-of-a-kind products and services.

Goldbug offers a unique go-to-market approach to develop regulatory strategies that connect with business goals, focus on enhancing potential revenue, reduce product failure rates, and optimize internal resources. With the collective genius of our team, we develop optimal strategies for a wide range of products and services:

  • Distributed and single-site in vitro diagnostics (IVDs)
  • Companion and complementary diagnostic products (CDx)
  • Laboratory developed tests (LDTs)
  • Digital health technologies
  • Precision medicine diagnostics
  • Diagnostic instrumentation and consumables

FDA Submissions

Developing a new diagnostic product for commercialization is a complex, rigorous, and costly undertaking. Test developers and assay manufacturers typically find navigation of the regulatory requirements for full market release of their products both challenging and time consuming. Goldbug Strategies provides the expertise to alleviate the burden of identifying the proper regulatory pathways and handles the often complicated submission process.

Our team consists of former senior FDA officials and technical reviewers, industry experts and laboratory gurus, policy specialists and strong project leaders. Our diverse backgrounds offer a unique blend of experience critical to creating a successful submission package. We offer full and ancillary services to execute submissions in an efficient and streamlined manner, as well as high value support negotiating desired outcomes with regulatory authorities for different regulatory submissions:

  • Premarket Approval (PMA)
  • De Novo Classification
  • Premarket Notification (510(k))
  • Investigational Device Exemption (IDE)
  • Breakthrough Device Designation
  • Q-Submissions and other FDA filings

IVD Total Product Life Cycle Support

The successful launch of an IVD product is a multidisciplinary process with cross-functional engagement from highly skilled teams. Companies are often challenged with resource constraints and infrastructure limitations as they advance their product through its life cycle. Goldbug Strategies serves as a “one-stop shop” for solutions required throughout different phases of product development and commercialization.

In addition to its regulatory expertise, Goldbug provides in-depth knowledge of scientific, technical, and clinical aspects the total product life cycle, ranging from product feasibility planning to post-market surveillance. We offer a comprehensive suite of services to support companies with the successful launch of their products:

  • Device Planning and Development
  • Design Control Process
  • Analytical Validation Studies
  • Clinical Trial Support
  • Quality Management System Implementation
  • Postmarket Compliance

Expert Advisory Opinion

Modern regulatory and legislative systems involve many complexities and intricacies that are subject to interpretation, especially health policies and regulatory guidance within the precision medicine field. Over the years, Goldbug Strategies has served as a trusted advisor to provide categorical expert conclusions on different regulatory matters, and often collaborates with other professional firms to enhance their services and help achieve desired outcomes for clients.

Goldbug works with the industry’s top professionals who are seeking leaders with deep knowledge of the regulatory and legislative processes. Our team implements a multifaceted approach to regulatory issues and challenges and has served as a reliable source of regulatory expertise for different professional service sectors:

  • Due diligence for industry investors
  • Regulatory interpretations for legal proceedings
  • Executive advising for Boards of Directors
  • Strategy rescue and authentication