The Auditing Group

What The Auditing Group does

The Auditing Group, Inc. (TAG), founded in 1999 and headquartered in Southampton, New Jersey, is a specialized professional services firm delivering GMP, GLP, GCP and QMS auditing, gap analysis, remediation, training and validation services to regulated industries. Its target buyers are compliance, quality assurance and regulatory affairs functions at pharmaceutical, biotechnology, medical device, dietary supplement, cosmetic, clinical/CRO, 503B outsourcing, food, laboratory, blood/cell/tissue, and software-systems companies. Service delivery is on-site or virtual, with international travel bundled into a single fixed turnkey price covering airfare, hotels, expenses, draft and final reports, and audit or training certificates.

The company's core offerings are organized as discrete audit verticals (GMP Pharma, Medical Device/QMSR/ISO 13485, 21 CFR Part 11, GCP/Clinical, Cosmetics, Dietary Supplements, Retail Market, Food Facilities, FCCA, 21 CFR Part 4 Combination Products, 503B) supplemented by a proprietary 21 CFR Part 11-compliant CAPA Manager software with 6-month ($59,995) and 12-month ($89,995) managed remediation plans, an SOP template library, GMP training programs, validation services, and 483/Warning Letter remediation. The technology layer is domain-specialized rather than platform-native: project management is Gantt-driven, SOPs and validation documents are template-based, and audit methodologies are codified rather than ML-automated. Revenue is generated primarily through fixed-fee professional services engagements ranging from $5,995 (one-day domestic audit) to $89,995 (12-month CAPA managed service), sold via field sales and website-sourced quote requests.

Go-to-market is enterprise field sales targeting regulated manufacturers globally, supported by offices in the United States, China (Suzhou) and India (Kukatpally). The firm operates as part of a larger family of businesses including GMP Publications (regulatory handbooks), GMP Boot Camps (training delivery), The Quality Groups (consulting), The Validation Group (validation services), CAPA Manager (software), and content portals (FDA.com, 483help.com, SOPLibrary.com, GXP News). The company is privately held, founder/operator-led with no disclosed external funding, and its named enterprise client base includes Amgen, Bayer, Merck, Novartis, Roche, Regeneron, Medtronic, IQVIA, LabCorp and the Bill & Melinda Gates Foundation.

Name

The Auditing Group

Legal name

The Auditing Group, Inc.

Website

https://auditing.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

11–50 employees

Short description

The Auditing Group is a US-headquartered professional services firm providing GMP, GLP, GCP and QMS auditing, remediation, training and validation services to pharmaceutical, medical device, dietary supplement, cosmetic, clinical and food companies in the US, China and India.

Ownership category

akta.pro rank

Product category

Regulatory Compliance Auditing Services

NAICS

Testing Laboratories and Services (54138), Testing Laboratories and Services (541380)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP) (HLAGAKAE)

akta.pro secondary industries

Manufacturing Quality, GMP Inspections & Compliance (HLAJADAG), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF), Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI), Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA) (HLAGAKAF)

Keywords

• GMP compliance auditing
• FDA regulatory consulting
• Quality assurance services
• Pharmaceutical audit services
• GxP training and remediation

Headquarters

HQ city

Burlington

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Audit Services: Turnkey on-site audits including transportation, hotels, expenses, draft and final reports, and audit certificates. Domestic US audits range from $5,995 (1-day) to $7,995 (3-day). International audits range from $7,995 (1-day) to $9,995 (3-day).
2. Training Services: On-site or virtual training programs including handbooks, workbook binders, and certificates. Pricing mirrors audit pricing (1-day $5,995 to 3-day $7,995 domestic; $7,995-$9,995 international).
3. CAPA Manager Managed Services: 6-month managed service plan at $59,995 or 12-month plan at $89,995, including dedicated CAPA manager, weekly meetings, onsite consulting, gap analysis audits, SOP library access, training, and project management support.
4. Combined Audit & Training Packages: Bundled offerings combining audits with training (e.g., 1-day audit + 1-day training for $7,995 domestic or $9,995 international).

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

The Auditing Group (TAG) provides turnkey GMP, GLP, GCP, and QMS auditing, gap analysis, remediation, and training services to regulated industries including pharmaceutical, medical device, dietary supplement, cosmetics, and clinical research organizations. The firm supports client compliance with U.S. FDA, EU EMA, ISO, Health Canada, NMPA, PMDA, and WHO regulatory requirements, delivering on-site and virtual audits, mock inspections, SOP template libraries, CAPA management, and 21 CFR Part 11 validation services.

Product overview

The Auditing Group (TAG) is a GMP/GLP/GCP/QMS auditing and remediation services company operating since 1998. The portfolio consists of core audit services (GMP Audits, Medical Device Audits, Clinical GCP Audits, Cosmetics GMP Audits, Dietary Supplement GMP Audits, Food Facilities GMP Audits, FCCA Audits, and 21 CFR Part 4 Audits) paired with specialized compliance services (21 CFR Part 11 Compliance, Validation Services, 483 Remediation, and 503b Outsourced Facility Audits). Add-on offerings include CAPA Manager (6 or 12-month remediation plans with dedicated SMEs), GMP Help Desk, GMP Training Programs, and an SOP Template Library. The company also maintains affiliated brands: GMP Publications (regulatory handbooks), GMP Boot Camps (training), and The Quality Groups (consulting). Services support compliance with U.S. FDA, EU EMA, ISO, Health Canada, NMPA, PMDA, and WHO regulations.

Differentiator

Problem solved

Functional benefit

Products and services

• GMP Audits
• Medical Device Audits
• Clinical GCP Audits Good Clinical Practice audits including CRO audits, investigator site audits, GCLP (Good Clinical Laboratory Practice), and clinical electronic systems compliance for pharmaceuticals and medical devices.
• Cosmetics GMP Audits FDA/EU/ISO mock audits, GMP training, turnkey FDA readiness, SOP templates, quality management systems, and CAPA management for cosmetics manufacturers.
• Dietary Supplement GMP Audits Compliance audits, GMP training, QMS templates, gap analysis, and turnkey SOP/procedure templates including document control, change control, deviations, complaints, and vendor qualification for dietary supplement manufacturers.
• Food Facilities GMP Audits Food facility GMP audits, certificates, SOP templates, and compliance support for food manufacturing, packaging, and holding operations per FDA regulations.
• FCCA Audits Factory Capability and Capacity Audits evaluating CMO/facility capabilities including GMP QMS review, DMR, DHR, DHF documentation, quality assurance processes, validation, and regulatory compliance.
• 21 CFR Part 4 Audits Combination product audits covering drug constituent, biologic constituent, and medical device compliance under 21 CFR Part 4 regulations.
• 503B Outsourced Facility Audits Pre-FDA inspection and gap analysis services for 503B outsourcing facilities compounding sterile medicinal products, supporting compliance with 21 CFR Parts 210/211 and USP standards.
• Validation Services Full validation and qualification services supporting pharmaceutical, medical device, biologics, laboratory equipment, software and systems including equipment validation, process validation, facility qualifications, software validation (21 CFR Part 11), analytical methods, and cleaning validation.
• 21 CFR Part 11 Compliance Services Electronic records and electronic signatures compliance audits, ALCOA++ data integrity assessments, EMA Annex 11 compliance, ISO 27001 security systems, and GAMP 5 validation services.
• 483 Remediation FDA 483, Warning Letter, and agency observation remediation services including training, QMS implementation, GMP design/build analysis, and as-built drawing management using Gantt-driven project management.
• CAPA Manager Dedicated CAPA Manager SME service providing turnkey GMP/QMS remediation with 6 or 12-month plans including weekly remote meetings, onsite consulting, gap analysis, audit support, SOP template library access, and training. Features Gantt-driven project management.
• GMP Training Programs On-site and virtual GxP training programs (1, 2, or 3-day sessions) covering GMP, GLP, GCP, ISO standards for pharmaceutical, medical device, cosmetics, dietary supplements, and clinical industries, including training materials and certificates.
• Retail Market GMP Certificate Program GMP certification program for retail market covering dietary supplements, vitamins, cosmetics, topicals, protein bars, drinks, and food products with gap analysis, remediation templates, and certificates of compliance.
• SOP Template Library Extensive library of Standard Operating Procedure templates, manuals, policies, validation documents, work instructions, and handbooks available for CAPA Manager members, covering GMP, GLP, GCP, quality control, and regulatory compliance areas.

Quantifiable outcome

• Over 1,400 GxP Compliance Audits, Gap Analysis, Training and Remediation projects completed worldwide
• +3 more outcomes

Named customers22 records

Segments10 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Six partnerships are on record, tiered core and minor.

• GMP PublicationscoreStrategic or Co-development PartnerGMP Publications is a related entity within the same family of businesses. They publish FDA regulation handbooks, CFR guides, and technical manuals used by The Auditing Group for training materials and client resources. John Cuspilich serves as Editor-in-Chief for GMP Publications.
• GMP Boot CampscoreStrategic or Co-development PartnerGMP Boot Camps provides on-site and virtual GxP training programs. The Auditing Group has partnered with GMP Boot Camps to deliver training as part of their turn-key audit and remediation services. John Cuspilich serves as Senior Instructor and CEO of GMP Boot Camps.
• The Quality GroupscoreStrategic or Co-development PartnerThe Quality Groups provides quality management services and is part of the same business family. The Auditing Group is a division of The Quality Groups. They also co-market services and share cross-promotional relationships with The Quality Groups.
• CAPA ManagercoreTechnology or IntegrationCAPA Manager is a software platform owned by the company providing CAPA management, SOP library access, and project management tools for remediation clients. Available at capamanager.com.
• Validations.com (The Validation Group)coreTechnology or IntegrationThe Validation Group (TVG) provides validation services for equipment, facilities, software, and processes supporting GxP compliance. They operate under the same business umbrella and cross-refer clients.
• FDA.comminorStrategic or Co-development PartnerFDA.com is a related website managed by The Auditing Group providing FDA regulatory information and resources. John Cuspilich manages the FDA.com website.

Scale indicators7 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Parexel International: Large CRO providing clinical trial services plus regulatory affairs and compliance consulting. Overlaps with TAG specifically on GCP audits, CRO qualifications, and clinical-related GxP work, though at significantly greater scale and as part of broader clinical mandates.
• NSF (formerly NSF International): Global public health and safety organization providing pharma, biotech, and medical device compliance services including GxP auditing, training, and certification. Broader scope than TAG (food, water, consumer products) but directly competes on pharma GxP audit and consulting work.
• BSI Group: Standards body and certification firm with a regulated-industries practice that delivers ISO 13485, MDSAP, GMP, and quality management training and auditing. Comparable to TAG on medical device QMS audits and ISO-based compliance support, though much larger and broader.
• Deloitte (Regulatory & Compliance Practice): Big 4 advisory firm with a life sciences regulatory and compliance practice delivering risk-based quality management, GxP auditing support, and remediation consulting. Competes with TAG on enterprise pharma audit-readiness programs, typically at larger scope and price points.
• PwC (Pharmaceutical & Life Sciences Advisory): Big 4 advisory firm offering regulatory compliance, quality, and risk consulting to pharma and medtech clients. Overlaps with TAG on GxP and FDA compliance engagements but bundles these with broader risk, finance, and technology services at a much larger scale.

Direct peers

• EduQuest: Independent GxP consulting firm specializing in FDA inspection readiness, GMP/QMS audits, and quality system remediation for pharma and medical device clients. Direct competitor to TAG on the same SME-led audit and remediation engagements.
• Maetrics: Life sciences regulatory and quality compliance consultancy providing GxP auditing, validation, and remediation services to pharma, biotech, and medical device companies. Closely comparable to TAG on FDA inspection readiness, GMP audits, and CAPA-driven remediation work.
• R&Q Solutions: Regulatory and quality consulting firm focused on medical device and combination product compliance, including ISO 13485 and FDA QSR/QMSR work. Direct overlap with TAG's medical device audit and combination device practices (21 CFR Part 4).
• Lachman Consultant Services: A long-standing independent GMP/GxP compliance and regulatory consulting firm serving pharmaceutical, biotech, and medical device companies. Direct overlap with TAG on FDA inspection readiness, GMP audits, mock audits, gap analysis, and remediation services for regulated manufacturers.

Emerging players

• ComplianceQuest (a Cloud Compliance Solutions company): Cloud-based quality and compliance management software provider for life sciences. Adjacent to TAG's CAPA Manager product line — competes in the 'systems of record' layer for CAPA, audit, and QMS workflows rather than the audit services themselves, but increasingly substitutes for parts of the engagement.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/the-auditing-group

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 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 The Auditing Group