Physician-led laboratory startup consulting for founders who need test menus, SOPs, quality systems, equipment, assays, and software aligned with CLIA requirements and real-world lab operations.
Led by a physician with hands-on experience working inside the clinical laboratory — not a regulatory-only consultant.
Laboratories rarely fail because of testing quality alone.
They fail because daily operations, documentation, staffing, and regulatory requirements were never aligned from the beginning.
Test menus don’t match staffing.
SOPs don’t match workflows.
Equipment is purchased before validation requirements are understood.
Quality systems exist on paper but not in practice.
Laboratory startup work is about building operations that inspectors, payers, and staff can all follow — without contradiction or rework.
New clinical laboratories subject to CLIA oversight
Physician-owned laboratories
Toxicology, molecular, and routine testing labs
Laboratories expanding test menus or complexity
Founders preparing for initial or follow-up inspections
If your laboratory will be subject to inspection or payer enrollment, startup work must be done strategically, not reactively.
We are a physician-led consulting firm that understands how laboratory regulation, documentation, inspections, and payer enrollment intersect in real-world lab operations.
That means:
Correct CLIA complexity selection
Staffing aligned to regulatory requirements
Documentation that supports inspections
SOPs aligned with test systems and workflows
Regulatory sequencing that avoids rework
Our goal is not just approval — it’s inspection readiness and operational stability.
Laboratory readiness begins with operational decisions — not applications.
This program focuses on designing how the laboratory will function day to day, and ensuring regulatory compliance is built into those operations rather than layered on afterward.
This program includes:
Laboratory Model & Ownership Review
Alignment of ownership, lab director structure, and regulatory responsibility with CLIA and state requirements.
Test Menu Planning
Guidance on selecting assays and methodologies that align with staffing, volume expectations, instrumentation, validation requirements, and reimbursement realities.
Instrumentation & Assay Selection
Advisory support for selecting analyzers, assays, and test systems that match the intended complexity level, staffing qualifications, workflow, and inspection expectations.
SOP & Documentation Framework
Development of lab-specific SOPs and documentation structures that reflect actual workflows, instruments, and responsibilities — not generic templates.
Quality Systems & QA Planning
Design of quality assurance and quality control programs that function operationally and stand up to inspection.
Staffing & Personnel Planning
Alignment of personnel roles, qualifications, and responsibilities with CLIA requirements and the planned test menu.
Laboratory startup plans fail when execution drifts.
The Guided Laboratory Launch program exists to ensure that operational decisions, documentation, validations, and regulatory requirements move forward together, without contradictions or gaps that surface later during inspection or billing.
This program is not about speed.
It is about coordination, accuracy, and follow-through while the laboratory transitions from planning to live operation.
Operational Execution Alignment
We ensure that test menus, workflows, staffing plans, and responsibilities are carried through exactly as designed — without last-minute changes that introduce compliance or inspection risk.
SOP Finalization & Validation Readiness
Oversight of SOP completion and validation planning to ensure documentation reflects actual instruments, assays, workflows, and personnel roles.
Regulatory & Inspection Preparation
Guidance through CLIA application steps and inspection readiness, with attention to how inspectors evaluate daily operations — not just paperwork.
Quality System Implementation
Ensuring QA and QC processes are not only documented, but realistically implementable by staff during routine operations.
Issue Detection & Course Correction
Identification of gaps, inconsistencies, or risks early — while they can still be corrected without disrupting launch or triggering deficiencies.
Most laboratory startup issues are not catastrophic failures.
They are small misalignments that compound over time.
This phase is designed to prevent:
SOPs that don’t match bench workflows
Validation gaps discovered during inspection
Staffing qualifications misaligned with test complexity
Quality systems that exist only on paper
Last-minute fixes that introduce new compliance risks
By the end of the Guided Laboratory Launch program, laboratories have:
Operations that match documentation
Documentation that matches inspection expectations
Staff prepared to execute defined workflows
Fewer surprises during inspection or early operation
Approval alone is not the goal.
A laboratory that can operate confidently on day one — and withstand scrutiny — is.
Our Turnkey Laboratory Startup engagement is designed for founders who want their laboratory built cohesively, defensibly, and without trial-and-error.
This is not a checklist service or a document package.
It is a structured, physician-led engagement that integrates operational design, documentation, regulatory sequencing, and launch oversight under a single framework.
The objective is not simply approval.
The objective is a laboratory that can operate day to day, pass inspection, and expand without rebuilding its foundation.
A turnkey engagement means we take responsibility for guiding and coordinating the decisions that determine whether a laboratory actually functions once testing begins.
This includes:
Operational Design & Sequencing
Finalizing how the laboratory will operate — test menus, workflows, staffing, and responsibilities — before documentation, validations, or inspections occur.
Test Menu, Instrumentation & Assay Alignment
Guidance on selecting and implementing instruments and assays that align with staffing qualifications, test complexity, validation requirements, and inspection expectations.
SOP & Quality System Development
Development of lab-specific SOPs and QA/QC structures that reflect real bench workflows and withstand inspection scrutiny.
Validation & Inspection Readiness Oversight
Ensuring validations, documentation, and operational readiness progress together, without last-minute gaps or contradictions.
Launch & Early-Operation Oversight
Maintaining visibility into readiness through launch so early operations do not expose documentation, staffing, or compliance weaknesses.
Turnkey Is:
Structured and high-accountability
Focused on operational reality, not templates
Designed to reduce inspection findings and rework
Built around how laboratories actually function
Turnkey Is Not:
A shortcut to opening
A guarantee of inspection outcomes
Daily laboratory management
Testing execution or validation performance
Our role is to design, align, and guide — not to operate the laboratory for you.
Turnkey laboratory startup support is best suited for founders who:
Want a single point of accountability during startup
Understand that operations and compliance are inseparable
Prefer structured guidance over reactive fixes
Value inspection readiness and long-term stability over speed
Laboratories that complete a Turnkey Startup engagement launch with:
Operations that match documentation
Documentation that matches inspection expectations
Staff prepared to execute defined workflows
Fewer deficiencies, delays, and surprises
Opening a laboratory is easy.
Opening one that holds up under scrutiny is not.
Laboratory startup work varies significantly based on how the laboratory will actually operate.
Test complexity, instrumentation, staffing qualifications, documentation requirements, validation scope, and inspection readiness all directly affect the level of work required to build a laboratory that can function day to day and withstand regulatory scrutiny.
Typical investment for Laboratory Startup services ranges from:
$5,000 – $25,000
Final investment is determined by:
Test menu and complexity level
Number and type of instruments and methodologies
SOP and quality system development required
Validation planning and inspection readiness scope
Level of coordination and oversight through launch
Laboratory startup costs are driven by operational decisions, not paperwork volume.
The cost of remediating deficiencies after opening — including failed inspections, documentation rewrites, revalidations, staffing corrections, or delayed enrollment — often exceeds the cost of building the laboratory correctly before testing begins.
Startup investment is best viewed as risk control:
Reducing inspection findings
Preventing operational contradictions
Avoiding rework that disrupts testing
Protecting the ability to scale or expand test menus later
Your investment covers:
Physician-led operational and regulatory guidance
Test menu, instrumentation, and workflow alignment
Lab-specific SOP and QA/QC system development
Validation and inspection readiness oversight
Coordination and accountability through launch
We do not charge for:
Speed
Volume
Generic templates
We charge for judgment, accuracy, and follow-through.
To maintain focus and clarity, laboratory startup investment does not include:
Performing laboratory testing or validations
Daily laboratory management or staffing
Specimen sourcing or client acquisition
Sales, marketing, or business development
These boundaries allow startup work to remain defensible and inspection-focused.
An initial consultation allows us to:
Confirm test complexity and regulatory scope
Identify potential operational or inspection risks
Define the appropriate level of startup support
Provide a clear, written scope and investment
Laboratory startup costs vary because laboratory operations vary.
This section explains what drives scope and investment.
Why is there such a wide investment range?
Laboratory startup complexity differs significantly based on test complexity, instrumentation, staffing, documentation requirements, and inspection readiness. A limited, low-complexity laboratory requires a very different level of support than a high-complexity operation with multiple assays and validations.
What factors increase the level of investment?
Investment increases as scope increases, particularly with:
High-complexity testing
Multiple instruments or methodologies
Extensive SOP and quality system development
Validation planning and inspection readiness support
Is this primarily documentation work?
No. Documentation is one component, but the primary focus is operational alignment — ensuring test menus, workflows, staffing, instruments, SOPs, and quality systems function together and withstand inspection.
Can services be scoped or phased?
Yes. Some laboratories engage us for targeted support, while others require end-to-end coordination. Scope is defined during the initial consultation and documented clearly before work begins.
Why not use templates or lower-cost consultants?
Generic templates often fail inspection because they do not reflect how a laboratory actually operates. Our work is lab-specific, defensible, and built around daily operations rather than paperwork alone.
Most laboratory failures are not caused by testing errors.
They are caused by early decisions that didn’t account for how the laboratory would actually operate day to day.
When test menus, staffing, instrumentation, SOPs, and quality systems are not aligned from the beginning, problems surface later — during inspection, billing, or growth — when fixes are far more costly.
Startup work done before opening allows these elements to be designed together, rather than corrected after the fact.
While laboratory startup services are comprehensive, we also provide standalone laboratory services
No.
CLIA approvals and inspection outcomes are determined by regulatory agencies.
What we do control is preparation, documentation accuracy, operational alignment, and readiness — which significantly reduces avoidable deficiencies and delays.
No.
We do not perform laboratory testing, run instruments, execute validations, or manage daily operations. We do have access to staffing and hiring. We can assist in creating validation plans.
Our role is to design, guide, and align laboratory operations so your staff can perform testing correctly and defensibly.
No.
We do not develop assays or design LDTs. We do have carefully selected partners that create custom assays and methods.
Our work aligns SOPs, validation planning, and documentation with existing instruments, assays, and manufacturer methodologies.
Yes.
Many laboratories engage us after encountering inspection findings, documentation gaps, or regulatory delays.
We assess the current state and determine whether remediation, documentation correction, or targeted support is appropriate.
No.
We do not assist with specimen sourcing, sales, or client acquisition.
Our focus is on laboratory operations, documentation, compliance, and inspection readiness.
Our laboratory startup services are designed for founders who understand that regulatory compliance, documentation, and inspection readiness are not optional — they are foundational.
We are a good fit when expectations are aligned and the goal is to build a laboratory that can withstand regulatory and payer scrutiny from the beginning.
You are launching a clinical laboratory subject to CLIA or state oversight
You want regulatory and inspection readiness addressed before testing begins
You understand that documentation and SOPs must be lab-specific and defensible
You value structured guidance over trial-and-error
You want clarity, sequencing, and accountability during startup
You are looking for shortcuts or minimal documentation
You want to open immediately and address compliance later
You expect guarantees around inspection outcomes or approval timelines
You are seeking specimen sourcing, sales, or client acquisition
You want someone to operate the laboratory on your behalf
Our role is to help laboratories launch correctly, not quickly at the expense of compliance.
A brief consultation allows us to:
Confirm your state, specialty, and payer goals
Identify potential credentialing challenges early
Recommend the appropriate scope and pricing