CLIA Lab Consultant

What CLIA Lab Consultant does

CLIA Lab Consultant is a Los Angeles-based, privately held laboratory consulting firm founded in 1999 by Michael Yu. It provides regulatory, startup, technical, personnel, and reimbursement consulting services to clinical laboratories, with explicit specialization in CLIA certification, state licensure, and accreditation across CAP, Joint Commission, COLA, ACHC, and AABB. Service coverage spans waived, moderate, and high-complexity laboratories as well as laboratory-developed testing (LDT) facilities, with documented reach across 22 U.S. states and 11 international countries including Canada, Israel, South Korea, Singapore, China, Ireland, France, England, Spain, Germany, and Chile.

The firm operates a tiered Lab Startup Program (Waived starting at $1,000, Non-Waived Moderate/High Complexity starting at $15,000, and a $2,500 Startup Consultation Program), supplemented by four core offerings: the CLIA Connect Personnel Placement Service for licensed Lab Directors and technical consultants; Technical Consulting and Compliance Support for ongoing regulatory operations; End-to-End Inspection Support with a claimed 100% pass rate across CAP, Joint Commission, COLA, CLIA, and state inspections; and Merger and Acquisition Advisory for laboratory transactions. Underlying technology is non-proprietary; the value proposition rests entirely on practitioner expertise, regulatory knowledge, and the bench of credentialed laboratory directors rather than any software or platform.

Go-to-market is direct enterprise field sales supplemented by referral networks, targeting four segments: clinical laboratories, biotechnology and life-science startups, healthcare provider networks, and IVD/pharma companies. Revenue mechanics are professional-services-based, combining fixed-fee program packages with hourly consulting time. The firm displays 25+ client logos across AI diagnostics, gene therapy, biotech, reproductive endocrinology, urgent care, and pharmaceuticals. No funding rounds, parent company, or institutional backing is disclosed; ownership and delivery center on founder Michael Yu.

Name

CLIA Lab Consultant

Legal name

CLIA Lab Consultant

Website

https://clialabconsultant.com

Company type

Private

Founded year

1999

Operating status

Operating

Short description

CLIA Lab Consultant is a Los Angeles-based laboratory consulting firm providing CLIA certification, state licensure, accreditation, personnel placement, and inspection support to clinical laboratories across 22 U.S. states and 11 countries, serving biotech, AI diagnostics, and healthcare provider clients since 1999.

Ownership category

akta.pro rank

Product category

Laboratory Consulting Services

NAICS

Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Clinical Research & Trial Central Laboratories (HLAFAMAL)

akta.pro secondary industry

Laboratory, Bioanalytical & Central Lab Staffing FSP (HLAGAOAI)

Keywords

• CLIA regulatory compliance
• Laboratory consulting services
• Clinical laboratory accreditation
• Lab startup consulting
• Laboratory personnel placement

Headquarters

HQ city

Los Angeles

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Laboratory Consulting Services: Project-based consulting engagements for CLIA certification, state licensure, accreditation, technical consulting, quality management system development, and inspection support. Revenue generated through fixed-fee programs and hourly consulting time.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

CLIA Lab Consultant provides regulatory, startup, technical, and reimbursement consulting services for clinical laboratories. The firm delivers end-to-end laboratory consulting covering CLIA certification and accreditation, state licensure in 22 U.S. states, international CLIA certification, quality management system development, technical compliance support, end-to-end inspection support, laboratory personnel placement, and billing and reimbursement strategy. Services are sold as fixed-fee programs (for example, waived lab startup from $1,000, non-waived lab startup from $15,000) and hourly consulting engagements targeting clinical laboratories, biotechnology startups, healthcare provider networks, and IVD/pharma companies.

Product overview

CLIA Lab Consultant offers a suite of laboratory consulting services organized around four core offerings: the CLIA Connect Personnel Placement Service for recruiting qualified laboratory directors and consultants; Technical Consulting and Compliance Support for ongoing regulatory compliance and operational oversight; End-to-End Inspection Support for pre-inspection preparation, survey day assistance, and post-inspection remediation; and Merger and Acquisition Advisory for transaction assessment. The Lab Startup Program provides structured entry paths including the Startup Consultation Program ($2,500), Waived Lab Startup Program (starting at $1,000), and Non-Waived Lab Startup Program (starting at $15,000), each designed for different laboratory complexity levels and startup stages.

Differentiator

Problem solved

Functional benefit

Products and services

• Lab Startup Program A comprehensive program providing price transparency for new laboratories to accurately budget for CLIA requirements for both waived and non-waived testing, including application assistance, procedures, and compliance documentation.
• Waived Lab Startup Program A specialized startup program for physician offices, dental offices, pharmacies, and mobile laboratories seeking to offer waived testing services such as urine drug screening, including CMS-116 form completion and state applications starting at $1,000.
• Non-Waived (Moderate and High Complexity) Lab Startup Program A startup program for moderate and high-complexity laboratories that simplifies the startup process following CLIA and accrediting organization guidelines, starting at $15,000, including CMS-116 and CMS-209 forms, proficiency testing enrollment, equipment selection, performance verification, IQCP, job descriptions, LIMS/LIS vendor selection, and customized QMS.
• Startup Consultation Program A consultation program for entrepreneurs and startups seeking expert guidance on laboratory operations and business model review, priced at $2,500 for two hours of consultation, covering CLIA startup, state licensure, accreditation, LDT validation, and investor-ready business plans.
• CLIA Connect Personnel Placement Service A placement service for Lab Directors (MD/DO/PhD), Clinical Consultants, Technical Supervisors, and Technical Consultants, including candidates licensed in states requiring laboratory personnel licensure such as California, Florida, Georgia, Hawaii, Louisiana, Nevada, New York, and Tennessee.
• Technical Consulting and Compliance Support Ongoing technical support for laboratory operations including CLIA applications, proficiency testing management, training and competency assessments, IQCP development, validation review, calibration verification, policies and procedures, regulatory updates, manufacturer recall assistance, routine on-site visits, and full inspection preparation and support.
• End-to-End Inspection Support Comprehensive inspection support consisting of pre-inspection audits, on-site or remote inspection day support, and post-inspection deficiency remediation for CLIA, state, and accrediting organization inspections with a 100% pass rate.
• Merger and Acquisition Advisory Advisory services for clinical laboratory transactions including comprehensive assessment of laboratory before transactions, liability minimization, and evaluation of buy-versus-build options for potential buyers.
• Quality Management System (QMS) Development Custom QMS development including policies and procedures compliant with CLIA and accrediting organization standards, covering pre-analytical, analytical, IQCP (Individualized Quality Control Plan), post-analytical, and general laboratory quality. Includes checklists, logs, requisitions, reports, training templates, and competency assessments.
• Billing and Reimbursement Services Billing and reimbursement consulting including NPI registration, PTAN (Medicare) enrollment, Medicaid enrollment, private insurance payer credentialing, CPT and PLA code review and optimization, and Proprietary Laboratory Analysis (PLA) code application submission.
• State Laboratory Licensure State laboratory licensure for both in-state and out-of-state laboratories, covering California, Connecticut, DC, Maine, Maryland, Nevada, New Jersey, New York, Pennsylvania, Rhode Island, and Washington.
• California Biologics License Services Initial, renewal, and change applications for California biological licenses required for facilities involved in platelet rich plasma (PRP), donor centers, and blood banks.
• International CLIA Certification International CLIA certification for overseas laboratories performing testing on samples originated from the United States, including clients in 11 countries such as Canada, Israel, South Korea, Singapore, China, Ireland, France, England, Spain, Germany, and Chile.

Quantifiable outcome

• 100% pass rate across all inspections including CAP, Joint Commission, COLA, CLIA, state inspections, and re-inspections

Named customers25 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• ProPharma Group: Larger full-service pharma, biotech, and medical device consulting firm with regulatory, quality, and compliance practices. Comparable on regulatory advisory overlap but offers a much broader portfolio than a CLIA-focused consultancy.
• IQVIA: Global clinical research services and life sciences consulting giant. Comparable as a broad incumbent serving many of the same biotech, pharma, and CRO clients, though IQVIA operates at vastly greater scale and competes primarily in larger enterprise engagements.
• NAMSA: Medical device and IVD-focused contract research organization and consulting firm. Comparable as a regulatory and laboratory-services provider to IVD manufacturers, but operates at significantly greater scale and breadth.

Direct peers

• MakroCare: Clinical research and regulatory affairs consulting firm serving pharma, biotech, and medical device clients across global markets. Comparable for its blend of clinical/regulatory advisory and CRO-adjacent services targeting similar client profiles.
• Compliance Insight: Regulatory and quality consulting firm focused on FDA-regulated industries including diagnostics and clinical laboratories. Comparable in niche, delivery model, and target client profile for outsourced regulatory expertise.
• The FDA Group: FDA regulatory and quality consulting firm helping life sciences companies navigate compliance, submissions, and inspections. Comparable as a similar-sized specialist consultancy whose core offering is regulatory advisory to FDA-regulated industries including labs.
• RQM+: Regulatory and quality consulting firm serving medical device, IVD, and combination product companies. Most directly comparable in terms of being a specialized regulatory/quality consultancy with deep lab-adjacent expertise and similar engagement model.

Emerging players

• BioAgilytix: Bioanalytical and central laboratory services provider for pharma and biotech. Comparable because its laboratory operations require the same CLIA-grade compliance expertise CLIA Lab Consultant provides, representing an adjacent lab-services competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CLIA Lab Consultant