Clinical laboratory consulting · Est. 2023 · Houston-based, serving labs nationwide
Labryte is a women-led consulting firm built by laboratory directors and quality experts. We help diagnostic, molecular, and physician-office labs launch, validate, and stay inspection-ready — without the typical regulatory drag.
Built on credentials that hold up in audit:
01 — Why Labryte
Clinical laboratories operate under some of the most demanding regulations in healthcare. We pair deep technical fluency — high-complexity test validation, molecular methods, BSL I–III workflows — with the operational discipline that turns a startup lab into an inspection-ready business.
We don’t hand off a stack of templates. We embed with your team, document the work to standard, and stay accountable through your first — and your next — inspection.
02 — Laboratory services
From CLIA application through ongoing QA monitoring, we deliver itemized or turn-key engagements tailored to physician-office, independent, and reference laboratories.
CLIA, CAP, and COLA application processing, lab design, method development, and recruitment — everything required to open with confidence.
Custom QA plans aligned to 42 CFR 493 covering pre-analytical, analytical, and post-analytical processes — plus ongoing maintenance retainers.
Plan, execute, and document validations for waived through high-complexity assays — including molecular, toxicology, immunology, and hematology panels.
Build clinically actionable, reimbursable test panels grounded in current coding, payer behavior, and clinical utility.
Mock inspections, gap analysis, and on-site coaching that walks your team into a real CLIA, CAP, or COLA audit ready to defend the work.
Standard operating procedures authored by working lab directors, paired with hands-on training for your technologists in new methodologies.
Match the right CLIA-approved PT program to each analyte — or design defensible alternative assessments for assays without one.
From feasibility through verification, we develop and document new methods so they hold up to inspector questions years later.
03 — How we work
01
A working session with your founders or directors. We map the lab’s goals, complexity, regulatory posture, and timeline before scoping a single deliverable.
02
Itemized statement of work, validation plans, and QA architecture — written to the standard an inspector will read it against.
03
Bench-side validation, SOP rollout, and technologist training. We sign documents, witness runs, and own the deliverables.
04
Ongoing QA maintenance, PT review, and inspection-readiness checks — so the lab you opened is the lab you keep operating.
Marketing services
Most marketing partners can’t read a test menu. We can. Our team translates clinical complexity into clear positioning, sales enablement, and launch programs — from rebrands to physician-facing collateral.
Staffing & recruiting
Specialized clinical laboratory talent is hard to source. We place part-time and full-time technical supervisors and board-certified laboratory directors nationwide — vetted against the same standards that run our clients’ floors.
04 — Leadership
Labryte is 100% woman-owned and operated. Our founders sit at the intersection of clinical science, lab operations, and regulatory affairs — and they remain hands-on in every engagement.
HCLD(ABB) · Chief Executive Officer
A board-certified High-complexity Clinical Laboratory Director with deep experience in molecular diagnostics, assay validation, and CLIA program leadership. Amanda directs the firm’s technical and regulatory practice.
MB(ASCP), MBA · Chief Operating Officer
An ASCP-certified molecular biologist with an MBA, Mary Beth leads operations, quality, and client engagement — turning regulatory complexity into the disciplined, repeatable workflows our clients rely on.
05 — News & insights
Planned editorial pillars for building search authority around validation, compliance, and lab operations — written by the people who do the work.
What inspectors actually look for, the documents that quietly delay applications, and how to sequence your build-out around them.
Documentation patterns, study sizing, and the small decisions that determine whether your validation defends itself in 2028.
A decision framework for early-stage labs balancing personnel regulations, payroll, and time-to-go-live.
06 — Start the conversation
Every engagement begins with a 30-minute scoping call — no slides, no pitch. We’ll listen, then come back with a written read on scope, timeline, and the regulatory shape of the work.
