QualityHub

Name

QualityHub

Legal name

QualityHub, Inc.

Website

https://qualityhub.com

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

11–50 employees

Short description

QualityHub is a boutique regulatory compliance and quality consulting firm that serves medical device, pharmaceutical, combination product, and biologics manufacturers with FDA inspection support, QMS consulting, remediation, training, and on-demand staff augmentation services.

Ownership category

akta.pro rank

Product category

Regulatory Compliance Consulting

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

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

akta.pro secondary industry

Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK)

Keywords

• Regulatory compliance consulting
• FDA inspection support
• Quality management systems
• Medical device consulting
• Pharmaceutical compliance services

Headquarters

HQ city

Orlando

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Professional Services Consulting: QualityHub generates revenue through professional services engagements including regulatory compliance consulting, FDA inspection support, quality systems auditing, compliance remediation, QMS consulting, clinical consulting, product development consulting, and project management. Revenue is derived from project-based fees, staff augmentation billing, and consulting retainers for ongoing compliance support.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

QualityHub provides expert regulatory, compliance, and quality consulting services to medical device, pharmaceutical, combination product, and biologics manufacturers. Its offering spans FDA inspection preparation and support, quality management system design and remediation, compliance gap closure, staff augmentation of QA/RA/clinical professionals, and customized training programs. Engagements are delivered by former FDA officials and veteran industry consultants on a project or retainer basis.

Product overview

QualityHub is a consulting services firm offering a comprehensive portfolio of regulatory, compliance, and quality expertise for the medical device, pharmaceutical, biologics, and combination products industries. The firm operates as a single unified service offering organized around core practice areas: Quality Systems Auditing, FDA Inspection Support, Compliance Remediation, Staff Augmentation, Quality Systems Training, QMS Consulting, Clinical Consulting, Regulatory Compliance Consulting, Product Development, Project Management, and Risk Management. Services are delivered by on-demand talent with 20+ years of experience. The company also maintains MediaHub (including QHub Insights), an educational content platform providing industry analysis, briefs, case studies, and regulatory news. QualityHub does not offer a software platform or AI-powered product—their offering is purely expert consulting services.

Differentiator

Problem solved

Functional benefit

Products and services

• Quality Systems Auditing Comprehensive auditing services for quality management systems to ensure compliance with FDA regulations and international standards, delivered to medical device and pharmaceutical manufacturers.
• FDA Inspection Support Expert preparation and support services to help medical device and pharmaceutical companies prepare for and navigate FDA facility inspections, including mock inspections and on-site readiness support.
• Compliance Remediation Services to identify, address, and resolve quality system deficiencies and compliance gaps, including retrospective review and remediation of legacy complaint records for regulated manufacturers.
• Staff Augmentation On-demand placement of experienced quality, regulatory, clinical, product development, manufacturing/operations, supply chain, and program/project management professionals to support client staffing needs across the regulated product lifecycle.
• Quality Systems Training Customized training programs, including FDA readiness training tailored to specific manufacturing sites and procedures, to prepare client teams for regulatory inspections and ongoing compliance.
• QMS Consulting Quality Management System consulting to help organizations design, implement, and maintain compliant quality systems aligned with FDA QMSR and ISO 13485 requirements.
• Clinical Consulting Expert guidance on clinical trials, study design, and regulatory requirements for clinical data supporting market authorization, delivered to medical device and pharmaceutical clients.
• Regulatory Compliance Consulting Advisory services covering FDA regulatory requirements, submissions, and ongoing compliance obligations for regulated medical device, pharmaceutical, combination product, and biologics manufacturers.
• Product Development Expert professionals to support product development and R&D projects, helping clients advance medical device and pharmaceutical products through development phases.
• Project Management Program and project management services with compliance mastery, focused on advancing regulated company initiatives and minimizing risk across complex product lifecycles.
• Risk Management Risk management services including supplier oversight, purchasing controls, and risk-based approaches to quality systems compliance for regulated manufacturers.

Quantifiable outcome

• Transformation of CAPA system recognized by FDA as one of the best systems ever seen
• +3 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators1 record

Recent moves6 records

Expansion highlights6 records

Direct peers

• The FDA Group: Regulatory and quality consulting firm staffed by former FDA inspectors and industry experts that provides medical device and pharma clients with inspection readiness, QMS, and compliance remediation services — directly overlapping QualityHub's core offering and buyer profile.
• ProPharma Group: Life-sciences consulting firm offering regulatory affairs, quality compliance, and pharmacovigilance services across pharma, biotech, and medical devices — directly comparable in service mix, regulated-industry focus, and enterprise buyer base.
• PharmaLex (now part of Cencora): Specialized regulatory affairs and compliance consulting for pharma and life sciences, including QMS, inspection prep, and quality compliance — comparable as a regulated-industries consulting peer with similar service lines and client segments.
• Lachman Consultant Services: Regulatory and quality compliance consultancy serving pharma and medical device companies on FDA inspection readiness, GMP compliance, and QMS remediation — highly comparable niche and small-firm structure to QualityHub.
• NAMSA: Medical-device-focused CRO and consulting firm providing regulatory, quality, and clinical consulting plus laboratory testing — directly comparable on med-device regulatory compliance, QMS, and FDA submission support.

Broad incumbents

• ICON plc: Global CRO offering regulatory affairs and quality consulting across pharma and devices via its Bioanalytical/Regulatory services — a much larger incumbent that competes for the same enterprise regulatory consulting budgets at global manufacturers.
• Parexel International: Large global CRO with a dedicated Regulatory & Access consulting practice serving pharma, biotech, and med device — competes with QualityHub for senior compliance budgets at the same regulated manufacturer buyers.
• IQVIA: Global life-sciences services company with regulatory, quality compliance, and inspection-readiness practices — competes for the same large enterprise compliance engagements and brings deep regulatory affairs capability.

Emerging players

• BSI Group (Regulatory & Clinical): Standards body and ISO 13485/QMS-focused consultancy offering regulatory and quality consulting for medical devices — comparable on ISO 13485 / QMS consulting, a core QualityHub service line.
• Greenlight Guru (Confluent Medical Technologies / Greenlight Guru): eQMS platform purpose-built for medical devices; not a direct consulting peer but a technological substitute that increasingly embeds QMS/inspection-prep capabilities and threatens traditional consulting-only firms like QualityHub.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/qualityhub
• Xx.com/QualityHubInc
• Facebookfacebook.com/qualityhubinc

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 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 QualityHub