QualityHub Employee Directory

Business Consulting and ServicesFlorida, United States11-50 Employees

QualityHub is a full-service regulatory, quality, and compliance consultancy serving the medical device, pharmaceutical, biologics, and combination products industries. The company is based in Orlando, Florida, at 976 Lake Baldwin Lane Suite 204, and employs between 11 and 50 people, with annual revenue reported in the range of $10 million to $25 million. QualityHub engages ex-FDA and former industry insiders to conduct quality audits and mock inspections, and provides expert services to teach, coach, and guide clients toward regulatory compliance and adherence to international standards. Its service offerings include Quality Systems Auditing, FDA Inspection Support, Compliance Remediation, Quality Systems Training, QMS Consulting, Clinical Consulting, Regulatory Compliance Consulting, Product Development, Project Management, and Risk Management, along with staff augmentation in Regulatory Affairs, Quality Assurance, Clinical, Product Development, Manufacturing and Operations, Program and Project Management, Research and Development, and Supply Chain. The firm has a history of addressing quality systems gaps identified in FDA-483s, warning letters, consent decrees, and other enforcement actions.

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