Our Services

Quality is a journey and we are committed to helping you along the way.


 

At QualityHub, our mission is to offer premier solutions in the area of applying quality principles. Our level of expertise allows us to provide the highest possible value to our clients. And our respect for client relationships drives us to exceed expectations at every turn.

 

Interim Professionals

The Interim Professionals (IP) Program is an innovative solution that provides temporary and long-term personnel to fill gaps in your organization, serve in interim positions, or supplement your staff when additional help is needed. The flexibility of using our Interim Professionals can work to your advantage, in that we provide prompt placement, varying durations of engagement, and simple, understandable billing rates. Interim Professionals can be added or removed with little advance notice. The broad skill-sets of our Interim Professionals cover a wide range of positions ranging from Vice Presidents, Directors, and Team Leads down to Professional and Worker level positions. Specific expertise includes: Manufacturing, Quality (including post-market activities), CAPA, Quality Managers, Product Development/Research & Development, Sourcing, Regulatory Affairs, and several other technical areas.

 

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Compliance Remediation

Addressing FDA-483s, Warning Letters, and Consent Decrees is a daunting task. While our auditing expertise can help determine how widespread and how severe the gaps may be, this is just the first step on the journey to achieve the needed compliance to FDA requirements. To achieve FDA Compliance requires a sound strategy, strong project oversight, and project management with close monitoring and accountability.

We can provide the needed Project (Strategic) Leads, Project Managers, and Subject Matter Experts who can help guide, coach and move the projects along. For more tactical work, our Associate Consultants can help execute on Quality System deliverables and documents. Our Interim Professionals solution can provide interim management and other personnel to ensure the work continues throughout the process of addressing the FDA-483s, Warning Letters, and Consent Decrees.

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Auditing

QualityHub has built its reputation as a world-class auditing organization. Our role in auditing the FDA regulated industry covers a wide variety of situations and a wide variety of companies. We help organizations meet their audit objectives via a broad array of audit types. We perform Baseline Audits, Supplier Audits, Expert Third Party Audits on behalf of FDA (following Recidivist Warning Letters and Consent Decrees), Due Diligence Audits, Mock-FDA Inspections/Audits, New Product Pre-Approval Audits, Verification Audits (following system improvements and CAPA activities) for a wide variety of FDA actions, Gap Assessments, and Process-Specific Audits and Reviews. We audit device and pharmaceutical companies worldwide.

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Regulatory Strategy

Responding to FDA-483s and Warning Letters is a unique challenge, and our extensive experience working with the FDA, as well as FDA-483s, Warning Letters, and Consent Decrees, can help your leadership team create and execute the plans to overcome your company’s challenges. Our former FDA and Industry Subject Matter Experts can help you craft the appropriate responses, or help you prepare for face-to-face meetings with the FDA.

We can help before, during and after FDA Inspections. Our FDA Inspection Readiness Our FDA Inspection Readiness Training helps you prepare, plan and rehearse for FDA Inspections.

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Quality System Optimization

The medical products industry spends considerable money on reactively addressing product issues, such as Recalls and Safety Alerts, as well as money spent on addressing FDA 483s and other quality deficiencies. In reality, the costs far outweigh the money spent to proactively ensure and maintain sustainable quality practices and implement strong risk practices with medical products. Not to mention the tremendous costs our industry pays as a result of increased FDA scrutiny, financial penalties, lawsuits, loss of brand integrity, etc.

Regardless of what stage you are in within the business lifecycle (i.e. start-up, growth, or maturity) QualityHub can help with product design, risk mitigation, Quality System/GMP development/improvement, global harmonization/integration/standardization, performance and system optimization, and preventative contingency strategies.

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