QualityHub
Business Consulting and ServicesFlorida, United States11-50 Employees
QualityHub is a full-service regulatory, quality, and compliance consultancy for the highly regulated Medical Device, Pharmaceutical, Biologics, and Combination Products industries. QualityHub works with only the best ex-FDA and former industry insiders to conduct quality audits and mock inspections, and we provide expert services to teach, coach, and guide clients so they comply with and adhere to an array of regulations and international standards. QualityHub’s reputation as a top compliance consultancy comes from our comprehensive experience and track record. We've played major roles in establishing strategies to address quality systems gaps communicated through FDA-483s, warning letters, consent decrees, and other enforcement actions. Our services include: • Quality Systems Auditing • FDA Inspection Support • Compliance Remediation • Quality Systems Training • QMS Consulting • Clinical Consulting • Regulatory Compliance Consulting • Product Development • Project Management • Risk Management ✅ We're also pros at developing, optimizing, and improving quality systems. Further, QualityHub’s Staff Augmentation services provide interim industry executives, subject matter experts (SMEs), and professionals in the areas of: • Regulatory Affairs (RA) • Quality Assurance (QA) • Clinical • Product Development • Manufacturing and Operations • Program and Project Management • Research and Development (R&D) • Supply Chain and Sourcing 👉 Connect with us today and discover what our trusted quality and compliance consultants, project managers, regulatory experts, and accomplished SMEs can do for you.