Quality 360

What Quality 360 does

Quality360 is a single-person quality management consulting practice founded in April 2019 by Anne MacNeil, a Certified Quality Auditor with over ten years of experience in quality investigations, supplier qualification, and vendor audits in the pharmaceutical and healthcare industry. The firm operates from a home-based or virtual office in Canada and delivers outsourced quality management services directly to clients in regulated industries. Its service portfolio spans audits, supplier management and qualification, investigations and CAPA effectiveness, documentation and procedure creation, training, risk management, inspection readiness, Lean and Six Sigma process improvement, and project management. The go-to-market is sales-led, direct engagement without intermediaries, marketed through a blog, LinkedIn, and social sharing rather than paid channels.

The business model is straightforward professional services revenue: quote-based consulting engagements with no publicly disclosed pricing, no productized offering, no software platform, and no recurring revenue mechanism. Quality360 serves seven verticals — Pharmaceutical, Medical Device, Clinical, Cannabis, Distribution, Dietary Supplement, and Food — with pharmaceutical as the primary focus. Despite language in third-party descriptions referencing "AI-powered root cause analysis," the underlying company data shows no proprietary technology, no AI/ML capabilities, and no software product; the practice is a manual consulting operation. There is no disclosed funding, no employees beyond the founder, no named customers, no partnerships, no patents, no awards, and no regulatory certifications, and the owner contact email ([email protected]) suggests a possible tie to a separate entity called "effyinc" that is not formally documented. The company remains an independent, founder-owned sole proprietorship-style practice.

Name

Quality 360

Website

https://quality360.ca

Company type

Private

Founded year

2019

Operating status

Operating

Short description

Quality360 is a Canada-based, single-person quality management consulting practice founded in 2019 by Certified Quality Auditor Anne MacNeil, providing outsourced audits, supplier management, CAPA, documentation, and inspection readiness services to pharmaceutical, medical device, cannabis, and other regulated-industry clients.

Ownership category

akta.pro rank

Product category

Quality Management Consulting

NAICS

Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Services (8741)

akta.pro primary industry

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

Keywords

• Quality management consulting
• Pharmaceutical quality audits
• Supplier qualification services
• Regulatory compliance consulting
• Inspection readiness services

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. Quality Management Consulting Services: B2B professional services revenue generated through consulting engagements for quality system implementation, supplier audits, supplier management, investigations, CAPA effectiveness, documentation, training, and regulatory compliance services for regulated industries.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Quality 360 is a single-person quality management consulting practice that delivers outsourced quality system services to regulated industries including pharmaceutical, medical device, clinical, cannabis, dietary supplement, food, and distribution. Service offerings include audits, supplier management and qualification, investigations and CAPA effectiveness, documentation and procedure creation, training, risk management, inspection readiness, Lean and Six Sigma process improvement, and project management. All services are delivered directly by founder Anne MacNeil, a Certified Quality Auditor with over ten years of experience.

Product overview

Quality 360 is a quality management consulting firm offering a portfolio of professional services to pharmaceutical and healthcare companies. The company provides a comprehensive suite of quality system services including audits, supplier management, investigations, documentation, training, risk management, inspection readiness, and process improvement (Lean/Six Sigma). These services are delivered by founder Anne MacNeil, a Certified Quality Auditor, and are designed to help regulated industry companies achieve and maintain compliance efficiently with reduced overhead costs.

Differentiator

Problem solved

Functional benefit

Products and services

• Quality Audits Quality audit services for evaluating compliance and identifying gaps in quality management systems for regulated industry companies.
• Supplier Management and Qualification Outsourced supplier qualification, supplier audits, and ongoing supplier quality oversight for companies in regulated supply chains.
• Investigations and CAPA Effectiveness Quality investigations and Corrective and Preventive Action (CAPA) effectiveness review services for regulated manufacturers.
• Documentation and Procedure Creation Procedures and technical writing for quality system documentation, including development and creation of quality management procedures and technical documents.
• Quality System Training Quality system training services for pharmaceutical, healthcare, and other regulated industry personnel.
• Risk Management Quality risk management services with focus on inspection readiness for regulated industry companies.
• Inspection Readiness Preparing manufacturing facilities for regulatory inspections and compliance audits in regulated industries.
• Lean and Six Sigma Lean implementation and Six Sigma process improvement services designed to create lean and compliant quality systems.
• Project Management Project management services for quality system implementation and improvement initiatives in regulated environments.

Segments7 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators1 record

Recent moves1 record

Expansion highlights3 records

Broad incumbents

• NSF International: Global public health and safety organization offering pharmaceutical and medical device quality consulting, training, and certification services — a larger incumbent serving the same regulated-industry QA market as Quality360.
• Parexel: Large global CRO offering comprehensive quality, regulatory, and compliance services across pharma and medical device — represents the scaled end of the regulatory QA consulting market where Quality360 competes for outsourced work.
• IQVIA: World's largest CRO with extensive quality assurance, regulatory compliance, and pharmacovigilance services — a dominant incumbent against which boutique QA consultancies like Quality360 position themselves on cost and personalization.
• NSF Health Sciences (formerly NSF-DBA): NSF's pharmaceutical and medical device consulting division offering audit, training, and quality system implementation — another scaled consulting alternative to boutique QA practices in the same regulated verticals Quality360 serves.

Direct peers

• Registrar Corp: Regulatory compliance services firm helping FDA-regulated companies with facility registration, U.S. agent services, and quality system compliance — comparable to Quality360's regulated-industry compliance support offering.
• EAS Consulting Group: Boutique regulatory and quality consulting firm serving FDA-regulated industries including pharmaceuticals, medical devices, dietary supplements, and food — overlapping with Quality360's multi-vertical GxP/GMP consulting model.
• The FDA Group: A US-based consulting firm specializing in FDA regulatory compliance, quality systems, and audit services for pharmaceutical and medical device companies — directly comparable to Quality360's pharmaceutical/medical device quality audit and inspection readiness offering.
• Regulatory Compliance Associates: Life sciences consultancy providing quality assurance, regulatory affairs, and compliance services to pharmaceutical and medical device manufacturers — directly comparable in service mix to Quality360's audit, CAPA, and inspection readiness portfolio.

Emerging players

• MasterControl: Provider of electronic quality management system (eQMS) software and related quality/compliance services for life sciences manufacturers — adjacent competitor that increasingly bundles consulting with its software platform.
• Greenlight Guru: Quality management software platform purpose-built for medical device companies — represents the tech-enabled approach to QA that competes with traditional consulting-only models like Quality360's.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat2 records

Key risks5 records

Key highlights5 records

Customer concentration

• Xtwitter.com/quality360ca
• LinkedInlinkedin.com/in/anne-macneil-7b7a0b22

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 Quality 360