Laboratory Consulting Services

What Laboratory Consulting Services does

Laboratory Consulting Services Inc. is a privately held regulatory compliance consultancy founded in 1998 and headquartered in Redwood City, California. The firm provides CLIA certification support, state licensure and accreditation assistance, Good Clinical Laboratory Practices (GCLP) guidance, validation studies for Laboratory Developed Tests (LDTs), Plans of Correction for regulatory citations, and designated Technical Supervisor services for clinical laboratories, biotechnology companies, public health laboratories, federal agencies, and law firms. The founders' prior roles — Jerry W. Hurst as manager of the California and federal CLIA inspection programs at California Laboratory Field Services, and Cynthia C. Hurst in molecular diagnostics customer technical service leadership at Chiron/Bayer, Celera, and Quest Diagnostics — form the substantive basis of the firm's regulatory credibility.

The business operates as a professional services practice with quote-based, non-publicly-disclosed pricing. Services are delivered through direct consulting engagements both onsite at client laboratories and remotely, with no software product, platform, or technology stack underlying the offering. The firm maintains a global client footprint spanning U.S. states and international engagements in Africa, South America, the Caribbean, Thailand, Northern Ireland, Australia, Germany, and Canada, including work with the NIH-sponsored HIV vaccine network and CDC Global AIDS Program. Client acquisition is driven by the founders' professional reputation, referrals, and direct outreach rather than formal marketing channels.

The firm is structured as a founder-owned boutique with 1-10 employees and no evidence of institutional capital, outside investors, or parent-company ownership. It has no subsidiaries, no documented M&A activity, no patents or trademarks, and no publicly disclosed revenue. The competitive position rests entirely on the personal credentials, regulatory relationships, and operational experience of its two principals.

Name

Laboratory Consulting Services

Legal name

Laboratory Consulting Services Inc.

Website

https://laboratoryconsultingservices.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

1–10 employees

Short description

Laboratory Consulting Services is a Redwood City-based regulatory consultancy providing CLIA certification, state accreditation, GCLP compliance, LDT validation, and Technical Supervisor services to clinical labs, biotech firms, public health laboratories, and federal agencies.

Ownership category

akta.pro rank

Product category

Clinical Laboratory Compliance Consulting

NAICS

Management, Scientific, and Technical Consulting Services (5416), Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK)

akta.pro secondary industries

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA), Laboratory Quality Systems, Accreditation & Proficiency Testing Programs (HLAJAIAM)

Keywords

• Clinical laboratory compliance
• CLIA certification consulting
• Laboratory accreditation services
• Regulatory compliance consulting
• Laboratory developed tests

Headquarters

HQ city

Redwood City

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

Revenue model

1. Laboratory Compliance Consulting Services: Professional consulting services for clinical laboratory licensing, CLIA certification, accreditation, and compliance. Includes validation studies for Laboratory Developed Tests, corrective action plans, and regulatory liaison services. Revenue generated through billable consulting engagements, both onsite and remote.
2. Technical Supervisor Services: Designation as Technical Supervisor on federal and state Personnel forms for client laboratories. Ongoing compliance oversight, inspection participation, policy review, and regulatory liaison services.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Laboratory Consulting Services provides regulatory compliance consulting for clinical laboratories seeking CLIA certification, state accreditation, and international laboratory compliance (GCLP). The firm delivers four core service lines: General Laboratory Services (licensure, certification, GCLP, procedure development, QA program development, document review, onsite audits), Post-Inspection Services (Plans of Correction for citations), Customer Technical Services (medical device technical support program setup), and Technical Supervisor Services (designated supervisor role on federal and state Personnel forms, inspection participation, and agency liaison).

Product overview

Laboratory Consulting Services is a consulting firm providing regulatory compliance expertise for clinical laboratories, not a software product company. The company offers four interconnected consulting service lines: General Laboratory Services (covering CLIA certification, GCLP compliance, and application support), Post-Inspection Services (corrective action plans), Customer Technical Services (medical device technical support program setup), and Technical Supervisor Services (designated supervisory personnel for regulatory compliance). These services are delivered by experienced clinical laboratory professionals and are tailored to clients seeking new laboratory licensure, CLIA certification, accreditation, or assistance with regulatory citations.

Differentiator

Problem solved

Functional benefit

Products and services

• General Laboratory Services
• Post-Inspection Services
• Customer Technical Services
• Technical Supervisor Services

Named customers23 records

Segments6 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators2 records

Recent moves4 records

Expansion highlights4 records

Direct peers

• COLA: COLA is a leading laboratory accreditation organization that evaluates labs against CLIA quality standards. Directly comparable as both an accreditation body and a provider of compliance guidance to clinical laboratories, though operating at much larger scale.
• Westgard QC: Westgard QC provides laboratory quality control training, certification, and consulting services — directly addressing the QA/QC portion of the LCS value proposition. Comparable as a niche consultancy serving clinical laboratories.
• Lighthouse Lab Services: Lighthouse Lab Services provides clinical laboratory consulting, CLIA certification assistance, and lab management services to clinical labs and biotech companies. Closest direct peer in terms of size, business model, and service offering focus.

Broad incumbents

• Accumen: Accumen is a larger healthcare consulting firm specializing in clinical laboratory operations, performance improvement, and accreditation. Comparable focus area but with broader service portfolio and institutional scale.
• College of American Pathologists (CAP): CAP operates the dominant laboratory accreditation program in the U.S. and provides regulatory compliance resources to clinical labs. A major incumbent in the same compliance ecosystem LCS serves, though primarily an accreditation body rather than a consultancy.
• A2LA (American Association for Laboratory Accreditation): A2LA is an ISO-based accreditation body serving testing and calibration laboratories. Operates in the same laboratory compliance space with broader international scope but does not specialize in clinical/CLIA consulting.
• The Joint Commission: The Joint Commission accredits hospital and healthcare laboratory services, often interacting with the same CLIA compliance frameworks LCS consults on. A much larger incumbent covering a broader range of healthcare accreditation.

Emerging players

• Quadax: Quadax provides laboratory information systems (LIS) and revenue cycle management with compliance-adjacent features. Comparable as a vendor to clinical labs but is primarily a technology vendor rather than a consulting firm.
• Data Innovations: Data Innovations provides laboratory middleware and quality management software that supports lab compliance workflows. Adjacent to LCS's consulting focus, serving the same clinical lab buyer with a technology rather than services approach.

Others

• ARUP Laboratories: ARUP is a national reference laboratory that also publishes laboratory best practices and consults on complex cases. Comparable as a clinical laboratory expert, but operates as a reference lab rather than a standalone consulting firm.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

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 Laboratory Consulting Services