QualityHub
QualityHub is a leading FDA compliance consulting firm dedicated to providing customized quality system solutions for medical device and pharmaceutical companies. With nearly 20 years of experience, they focus on processes, people, and results to help clients achieve extraordinary results and ensure compliance with regulatory requirements. Their services include product development, CAPA, complaint handling, production controls, supplier controls, internal auditing, management controls, document control, drug GMP, clinical compliance, and training. They emphasize integrity, customer success, and continuous improvement, with a strong international presence and a transition to an employee-owned business model.
Industries
Nr. of Employees
small (1-50)
QualityHub
Products
QReview (document review subscription)
Annual subscription product that provides a set number of on-demand hours for remote document review and consulting by SMEs, including secure document handling, NDA/subscription agreements, reviewer CVs, and optional peer review.
QReview (document review subscription)
Annual subscription product that provides a set number of on-demand hours for remote document review and consulting by SMEs, including secure document handling, NDA/subscription agreements, reviewer CVs, and optional peer review.
Services
On-site and remote QMS auditing services covering baseline, gap, verification, certification, QSIT, supplier and due-diligence audits; tailored audit planning and remote audit workflows.
Regulatory consulting for FDA remediation, preparation for inspections, development of compliance master plans, and support responding to FDA-483s, warning letters and consent decrees.
Annual subscription service providing on-demand remote document review by subject-matter experts for quality, technical and regulatory documents, with secure file transfer and optional peer review.
Customized programs for QMS development, record remediation, process improvement, and sustainable compliance aligned to US and EU regulatory expectations.
Regulatory strategy and submission planning for premarket activities, including regulatory meeting requests and preparation of submission content.
Post-market risk management, health hazard evaluations, updates to risk management files and support for risk-based decision making.
On-site and remote QMS auditing services covering baseline, gap, verification, certification, QSIT, supplier and due-diligence audits; tailored audit planning and remote audit workflows.
Regulatory consulting for FDA remediation, preparation for inspections, development of compliance master plans, and support responding to FDA-483s, warning letters and consent decrees.
Annual subscription service providing on-demand remote document review by subject-matter experts for quality, technical and regulatory documents, with secure file transfer and optional peer review.
Customized programs for QMS development, record remediation, process improvement, and sustainable compliance aligned to US and EU regulatory expectations.
Regulatory strategy and submission planning for premarket activities, including regulatory meeting requests and preparation of submission content.
Post-market risk management, health hazard evaluations, updates to risk management files and support for risk-based decision making.
Expertise Areas
- FDA inspection preparedness and remediation
- Quality management system (QMS) development and remediation
- Quality system auditing (remote and on-site)
- CAPA systems and root-cause investigation
Key Technologies
- Secure cloud-based document storage and SharePoint
- Video conferencing and remote collaboration tools for audits
- Electronic QMS and CAPA system integration
- Statistical trend analysis and quality data analytics
News & Updates
Guidance on building effective Corrective and Preventive Actions (CAPA) systems.
Guidance on building effective Corrective and Preventive Actions (CAPA) systems.