Strategic Advisory and Consulting for Analytical & Clinical Laboratories and the Companies That Support Them
Ron Brooks Consulting provides regulatory-driven laboratory advisory services, including laboratory regulatory gap analyses and defensibility assessments for clinical and analytical laboratories.
We help laboratories, lab leaders, and lab-facing companies reduce regulatory risk, build defensible quality systems, and make confident decisions under scrutiny. From hands-on consulting to executive-level advisory, our work is grounded in real-world laboratory operations, not just theory.
When Experience Matters More Than Speed
Organizations typically reach out when:
Regulatory expectations begin to outpace internal systems
Audits feel passable — but not defensible
Quality systems exist on paper, not in practice
Growth introduces risk instead of confidence
Products or platforms struggle to gain traction in regulated labs
If any of this sounds familiar, clarity usually matters more than execution.
Who We Work With
Analytical & Clinical Laboratories
Audit readiness, quality system development & defensibility, operational clarity.Laboratory Leadership & Public-Sector Stakeholders
Executive advisory, governance, and decision support during growth or transition.Private Equity Investors & Lab Acquirers
Regulatory risk assessment and diligence support.Lab-Facing Companies
Advisory for companies that sell into, support, or scale alongside regulated labs.
How We Help
Clinical Laboratory Advisory Services
Executive-level perspective on regulatory exposure, governance, and defensibility.Federal Regulatory Readiness
Structured assessment and transformation aligned with federal-style scrutiny.Clinical Laboratory Consulting
Hands-on execution, validation support, and quality system implementation.Analytical & Specialty Laboratories
Support across complex, regulated testing environments.
Why Clients Work With Ron Brooks Consulting
Former laboratory operator — not a career compliance consultant
Experience across clinical, analytical, and regulated testing environments
Deep understanding of how regulators, auditors, and inspectors think
Ability to bridge quality requirements with operational reality
Trusted by laboratories and lab-facing companies
The goal isn’t to pass audits; it’s to be defensible when it matters.
Representative Experience
Advising clinical and analytical laboratories on audit readiness and quality system defensibility
Supporting lab-facing companies aligning products with regulated clinical and analytical laboratory environments
Guiding leadership teams through regulatory exposure and growth transitions
How Engagements Typically Begin
Engagements usually start with a short conversation to understand risk exposure, objectives, and context.
From there, work may include:
Fixed-scope assessments
Ongoing advisory retainers
Fractional leadership support
Hands-on consulting where execution is required
All work products are tailored to your company, not templated.
Ready to Talk?
If you’re navigating regulatory pressure, growth, or strategic uncertainty, a short conversation can clarify next steps.

