Case Studies

International Pharmaceutical Company Earns FDA Recognition for CAPA System Overhaul
Case Studies

International Pharmaceutical Company Earns FDA Recognition for CAPA System Overhaul

Challenge: Prioritizing the “Preventive” in “Corrective and Preventive Actions” When QualityHub is brought on to do CAPA system revisions, it...
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Resolving a Corporate Warning Letter and Laying New Groundwork
Case Studies

Resolving a Corporate Warning Letter and Laying New Groundwork

Challenge: Compounding Issues Come to a Head A global leader in cardiovascular health (henceforth known as the Client) reached out...
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Overcoming Staffing Issues to Gain Compliance – Case Study
Case Studies

Overcoming Staffing Issues to Gain Compliance – Case Study

Back Challenge: Hitting a staffing roadblock A leader in In-Vitro Diagnostics (henceforth referred to as the Client) reached out to...
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QReview Case Studies
Case Studies

QReview Case Studies

Case Studies: QReview  QReview is QualityHub's latest offering to clients, an On-Demand remote document review and consulting service, that gives...
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Auditing Case Studies
Auditing Case Studies FDA Audit Preparation

Auditing Case Studies

At QualityHub, we have experience in FDA auditing for several types of companies and situations. Here are three examples of...
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Case Study: Regulatory Strategy
Case Studies FDA Regulatory Consulting Regulatory Strategy

Case Study: Regulatory Strategy

At QualityHub, we have experience in regulatory strategies for several types of companies and situations. Here are two examples of...
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Two Case Studies for FDA Compliance Remediation
Case Studies FDA Regulatory Consulting Remediation

Two Case Studies for FDA Compliance Remediation

At QualityHub, we have experience in FDA compliance remediation for several types of companies and situations. Here are two examples...
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Case Study: Quality System Optimization
Case Studies Quality Management Systems

Case Study: Quality System Optimization

At QualityHub, we have experience in quality systems for several types of companies and situations. Here are nine examples of...
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Case Study: Warning Letter
Case Studies FDA Regulatory Consulting

Case Study: Warning Letter

At QualityHub, we have experience in warning letters for several types of companies and situations. Here are four examples of...
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Case Study: Consent Decree Projects
Case Studies FDA Regulatory Consulting

Case Study: Consent Decree Projects

At QualityHub, we have experience in consent decrees for several types of companies and situations. Here are two examples of...
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Case Study: Staff Augmentation Program
Case Studies Staff Augmentation

Case Study: Staff Augmentation Program

At QualityHub, we have experience in staff augmentation for several types of companies and roles. Here are four examples of...
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