Insights

Client Overcomes Consistent Struggles from Recidivist Warning Letter Issues
Case Studies

Client Overcomes Consistent Struggles from Recidivist Warning Letter Issues

Recidivist warning letters are unique. They’re so unique, in fact, that many companies don’t realize...
Staffing Support Leads to Successful Resolution of Consent Decree
Case Studies

Staffing Support Leads to Successful Resolution of Consent Decree

A leading cardiovascular company (henceforth known as the Client) initially approached QualityHub after receiving multiple...
Resolving Consent Decree Issues with QualityHub as Third-Party Experts
Case Studies

Resolving Consent Decree Issues with QualityHub as Third-Party Experts

Consent decrees, when left unaddressed, can quickly escalate into additional costly penalties such as removal...
Rigorous Corporate Audits Saves Client Future Headaches
Case Studies

Rigorous Corporate Audits Saves Client Future Headaches

Top executives can delegate responsibilities to a quality system like auditing, but they cannot escape...
CAPA System Overhaul
Case Studies

CAPA System Overhaul

When QualityHub is brought on to do CAPA system revisions, it is often more reactive...
Resolving a Corporate Warning Letter and Laying New Groundwork
Case Studies

Resolving a Corporate Warning Letter and Laying New Groundwork

A global leader in cardiovascular health (henceforth known as the Client) reached out to QualityHub...
Overcoming Staffing Issues to Gain Compliance – Case Study
Case Studies

Overcoming Staffing Issues to Gain Compliance – Case Study

A leader in In-Vitro Diagnostics (henceforth referred to as the Client) reached out to QualityHub...
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...
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....
Case Studies: Regulatory Strategy
Case Studies FDA Regulatory Consulting Regulatory Strategy

Case Studies: Regulatory Strategy

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

Case Studies: FDA Compliance Remediation

At QualityHub, we have experience in FDA compliance remediation for several types of companies and...
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....
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....
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....
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....