QUALITY ASSURANCE SYSTEMS, INC.

What QUALITY ASSURANCE SYSTEMS, INC. does

Quality Assurance Systems, Inc. (QAS) is a privately held professional consulting firm founded in 1990 and headquartered in Mooresville, North Carolina, with a second US office in Scottsdale, Arizona. The firm specializes in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Clinical Laboratory Practice (GCLP) compliance auditing, computer system validation, and expert testimony, serving pharmaceutical, biotechnology, biologics, and medical device sponsors, contract research organizations, and law firm clients. QAS reports having served more than 250 clients and conducted over 100 audits across more than 30 countries on six continents, delivered by a multilingual team fluent in English, French, and Spanish.

The company's service portfolio is organized into four pillars: Audits & Assessments (clinical investigator, vendor, laboratory, and regulatory submission audits; inspection readiness); Computer System Related Services (computer system validation, CSV audits, user acceptance testing, and Interactive Response Technology/IXRS setup validation and monitoring); Compliance & Investigations (expert testimony, application integrity policy auditing, data trend analysis, and mock regulatory inspections); and Consulting & Training (GCP compliance consultation, quality systems development, SOP evaluation, and GCP audit training). A distinguishing technical capability is the firm's Data Trend Analysis methodology, designed to detect clinical research fraud and misconduct through systematic pattern review, alongside programmatic validation of IRT/IXRS randomization logic executed in a virtual study environment. QAS also delivers computer system validation against 21 CFR Part 11 and maintains GDPR readiness for international clients.

QAS operates a B2B project-based professional services model with quote-based, scope-tailored pricing and no publicly disclosed rate cards. The firm is led by Founder and Principal Consultant Barry J. Renaud and President Vincent M. Dailey, with a total headcount of approximately five employees; both principals personally deliver engagements. The go-to-market motion is direct enterprise field sales built on consultation-based engagement, with customer acquisition driven by industry conference presentations and referrals rather than digital marketing. The firm is privately held with no disclosed institutional investors, no funding rounds, no public listing, and no M&A activity.

Name

QUALITY ASSURANCE SYSTEMS, INC.

Legal name

Quality Assurance Systems, Inc.

Website

https://qasinc.com

Company type

Private

Founded year

1990

Operating status

Operating

Headcount range

1–10 employees

Short description

Quality Assurance Systems, Inc. is a privately held GCP/GLP/GCLP compliance auditing and computer system validation consulting firm serving pharmaceutical, biotechnology, medical device, and law firm clients since 1990.

Ownership category

akta.pro rank

Product category

Biomedical Regulatory Compliance Consulting

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

akta.pro secondary industries

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD), Enterprise Application Testing & QA Services (BPAEAGAI)

Keywords

• Clinical trial auditing
• GCP compliance consulting
• Computer system validation
• Biomedical quality assurance
• Regulatory compliance auditing

Headquarters

HQ city

Mooresville

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Professional Consulting Services: B2B consulting engagements including GCP/GLP/GCLP audits, compliance consultations, and quality systems development. Revenue generated through project-based professional services fees for auditing, training, expert testimony, and compliance consulting engagements.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Quality Assurance Systems, Inc. (QAS) is a specialized consulting firm delivering Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Clinical Laboratory Practice (GCLP) compliance auditing, computer system validation, and expert testimony services to sponsors of biomedical research and law firms. The company conducts audits of investigator sites, laboratories, vendors, sponsors, and computer systems used in clinical trials, and supports clients through inspection readiness, regulatory submissions, and litigation.

Product overview

Quality Assurance Systems, Inc. (QAS) is a specialized quality assurance and compliance consulting firm serving the biomedical research industry since 1990. The company operates as a unified service organization offering four primary service pillars: Audits & Assessments (clinical investigator and vendor audits, laboratory audits, inspection readiness, regulatory submissions), Computer System Related Services (validation, UAT, IRT/IXRS monitoring), Compliance & Investigations (regulatory inspections, expert testimony, data trend analysis), and Consulting & Training (GCP compliance, quality systems development). QAS has served more than 250 biomedical research and law firms, with auditors fluent in English, French, and Spanish who have performed over 100 audits in over 30 countries. The company also provides specialized Technical and Specialty Service Audits covering Data Management, SAS Programming, Statistics, Drug Safety & Pharmacovigilance, and Computerized Systems.

Differentiator

Problem solved

Functional benefit

Products and services

• Audits & Assessments Comprehensive audit services including Clinical Investigator and Vendor Audits, Clinical and Assay Laboratory Audits, Inspection Readiness Assessments, and Clinical Study Report and Regulatory Submissions Audits. Targeted at sponsors of clinical research needing GxP compliance validation.
• Computer System Related Services Validation and testing services for computerized systems including Computer System Validation, Computer System Validation Audits, User Acceptance Testing, and Interactive Response Technology (IXRS) Setup Validation and Monitoring Services. Targeted at sponsors and CROs using IRT/IXRS and EDC platforms.
• Compliance & Investigations Regulatory compliance and investigation services including Inspection Readiness, Expert Testimony, Application Integrity Policy Auditing & Consulting, Data Trend Analysis, and Mock Regulatory Inspections. Targeted at sponsors needing regulatory defense and law firms requiring expert witnesses.
• Consulting & Training Professional consulting and training services including GCP and Clinical Audits Training, GCP Compliance Consultation, Quality Systems Consultation & Development, and SOP Evaluation & Development. Targeted at biomedical research sponsors and their staff.
• GxP Audit Services (GCP/GLP/GCLP) Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Clinical Laboratory Practice (GCLP) audits at investigator sites, laboratories, sponsors, and vendors supporting development of experimental drugs, biologics, and medical devices. Targeted at biomedical research sponsors.
• Expert Testimony Services Expert and discovery witness services and testimony provided to corporate and outside legal counsels in matters involving clinical research compliance and misconduct. Targeted at law firms handling pharmaceutical and clinical research litigation.

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators4 records

Recent moves4 records

Expansion highlights4 records

Broad incumbents

• ICON plc: Global CRO and healthcare intelligence company providing clinical research and QA/compliance services. Comparable to QAS as a destination for GxP audit work, but at vastly greater scale and geographic reach.
• PharmaLex (now part of Cencora): Global regulatory affairs, quality, and compliance consultancy serving pharma and biotech. Overlaps with QAS on GxP auditing and quality systems consulting, but operates at significantly larger scale across multiple service lines.
• Charles River Laboratories: Provides CRO, laboratory, and GxP quality/compliance services to pharma and biotech. Overlaps with QAS on GLP/GCP auditing and computer system validation engagements within a much larger scientific services portfolio.
• Advarra: Provides IRB, IBC, biosafety, and GxP quality/compliance services to clinical research sponsors and CROs. Comparable to QAS in GCP quality oversight but with a much broader technology-enabled service portfolio.
• Parexel International: One of the largest global CROs offering integrated clinical development, regulatory, and quality assurance services. Competes with QAS for sponsor QA budgets but as part of a much wider full-service offering.

Direct peers

• Lachman Consultant Services: Independent US consulting firm providing GCP/GLP compliance, audit, and regulatory affairs services to the pharmaceutical industry. Highly comparable boutique structure to QAS, serving similar sponsor and legal clients.

Emerging players

• BioAgilytix Labs: Bioanalytical and GCLP-compliant laboratory supporting pharma/biotech clinical research. Overlaps with QAS on GCLP audit readiness and laboratory quality services but delivers assay work rather than audits.
• Greenlight Guru: eQMS and quality management software platform for life sciences companies. Adjacent to QAS's Quality Systems Consultation & Development services, offering a software-enabled alternative to consulting-based QMS work.
• CluePoints: Risk-based quality management and centralized statistical monitoring platform for clinical trials. Comparable to QAS's Data Trend Analysis fraud-detection capability but delivered as technology-enabled SaaS rather than consulting.

Others

• NetworkPharma: Specialist provider of GCP and clinical research training and education services to the pharma/biotech industry. Comparable to QAS's GCP and Clinical Audits Training service line, though primarily a training/education rather than audit business.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks4 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/QAS-Inc-Global
• LinkedInlinkedin.com/company/quality-assurance-systems-inc.

Compliance3 records

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 QUALITY ASSURANCE SYSTEMS, INC.