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.

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When Experience Matters More Than Speed

Clinical laboratory advisory support for regulatory readiness and audit preparation

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

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.

Book a Strategic Advisory Conversation