IVD Consulting LLC is a regulatory and funding strategy consulting firm dedicated to helping in vitro diagnostic companies navigate complex U.S. regulatory pathways and advance their programs efficiently toward FDA clearance. The firm specializes in aligning regulatory strategy, development planning, and non-dilutive funding to reduce risk, avoid rework, and accelerate time to market—particularly for infectious disease and medical countermeasure diagnostics.

The company was founded in February 2025 by Dr. Kristy Stoudt. Dr. Stoudt is a regulatory scientist with a PhD in Microbiology and Immunology and deep experience across the full lifecycle of diagnostic development and review. Over the course of 10 years, she has held key regulatory roles at the FDA, Biomedical Advanced Research and Development Authority (BARDA), and within industry.

• Lead Scientific Reviewer and EUA Team Lead, Division of Microbiology Devices-FDA

• Project Officer, Diagnostics Division-BARDA

• Director of Regulatory Affairs-Industry

Leveraging her blended experience across government and industry, Dr. Stoudt partners with IVD developers to offer unique insight into effectively planning for and applying to government solicitations, aligning product development plans with regulatory requirements, and meeting FDA expectations, avoiding common pitfalls, and streamlining regulatory review processes by delivering complete and compliant submissions.