Quality System Auditing
QualityHub has extensive experience in performing onsite and remote audits for medical device, drug, biologic, and combination product manufacturers who operate in a globally regulated environment.
Audits we can perform for your company:
Remote Quality Management System Audit
Baseline QMS Audit
Pre-Approval Inspection
Verification Audit
Certification Audit
Mock FDA Inspection
QSIT Audit
And more!
Clinical Consulting
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Quality Management Systems Consulting
QualityHub will guide you through the development of a clear roadmap to build the foundation for sustainable compliance and continuous improvement.
Development of QMS Compliance/Quality Plans
Quality Management System Development, Improvement & Optimization
QMS Record Remediation (CAPAs, Complaints, DHFs, RMFs, etc.)
Alignment of Quality Management Systems Post Merger/Acquisition
Alignment of Drug/Biologic/Medical Device QMS for Combination Products
FDA Regulatory Compliance Consulting
Whether your company is facing an FDA 483, Warning Letter or Consent Decree, QualityHub can help your leadership team create and execute the plans to overcome your company’s FDA regulatory compliance challenges.
Finding your gaps is just the beginning. QualityHub’s FDA regulatory compliance experts can help you accomplish the work needed to bring your organization into compliance.
We can provide the needed quality system project (strategic) leads, project managers, and subject matter experts who can help guide, coach and move the critical project along.
For more tactical work, our associate consultants can help execute on quality system deliverables and documents. Our interim quality professionals solution can provide interim management and other personnel to ensure the work continues throughout the process of addressing your FDA 483, Warning Letter or Consent Decree.
Technical Consulting
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FDA Inspection Support
QualityHub provides a wide variety of services that are intended to prepare companies for successful FDA Inspection. We have a team of former FDA investigators who can perform mock GMP/QMS inspections, Mock BiMO inspections, and Mock For-Cause Inspections for Pharmaceuticals, Medical Devices, IVDs, and Biologics. Our FDA inspection support services can be provided in any combination and can be customized based on your needs and their unique regulatory situation. These services are designed to provide your employees with an opportunity to practice their delivery of information and data during an inspection so that miscommunication and FDA 483 observations are minimized. These exercises can help identify potential inspection risks, whether they are related to quality, compliance, or logistics for inspection management.
Product Development
QualityHub understands the challenges of new product development and obtaining regulatory approvals in a competitive environment where time-to-market matters.
Let us help you with your:
Strategic Planning
Regulatory Submissions
Independent Reviews for Device Design Reviews
Design History File (DHF) and Technical File Development
Human Factors Engineering
Project Management
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Remediation
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Risk Management
Effective risk management requires a beginning-to-end approach to establishing, supporting and sustaining device safety throughout the product lifecycle.
Let our team of quality and engineering professionals help you with:
Risk Management Program Development
Risk Management File Development & Remediation
Health Hazard Evaluations (HHE)
Post-Market Risk Management Support
Staff Augmentation
Whatever your staffing needs may be, QualityHub can quickly mobilize the right balance of industry expertise and skills to deliver immediate results.
Our temporary staffing program provides interim industry executives, subject matter experts and professionals in the areas of:
Quality
Research & Development
Manufacturing
Supply Chain
Operations
Clinical
Regulatory Affairs
Quality System Training
QualityHub has subject matter experts with demonstrated excellence in speaking, training and conducting educational workshops. Our passion for learning inspires our trainings and allows us to develop personalized workshops and training experiences that will best fit your company’s culture and environment.
Examples of trainings we provide:
FDA Inspection Readiness
Quality Management System Training (Good Manufacturing Practices)
EU MDR Requirements
Risk Management
Corrective and Preventive Action (CAPA)
And many more!