Recidivist warning letters are unique. They’re so unique, in fact, that many companies don’t realize...
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
Consent decrees, when left unaddressed, can quickly escalate into additional costly penalties such as removal...
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
When QualityHub is brought on to do CAPA system revisions, it is often more reactive...
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
A leader in In-Vitro Diagnostics (henceforth referred to as the Client) reached out to QualityHub...
QReview Case Studies
QReview is QualityHub's latest offering to clients, an On-Demand remote document review and consulting service,...
Auditing Case Studies
At QualityHub, we have experience in FDA auditing for several types of companies and situations....
Case Studies: Regulatory Strategy
At QualityHub, we have experience in regulatory strategies for several types of companies and situations....
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
At QualityHub, we have experience in quality systems for several types of companies and situations....
Case Study: Warning Letter
At QualityHub, we have experience in warning letters for several types of companies and situations....
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
At QualityHub, we have experience in staff augmentation for several types of companies and roles....
