A global cardiovascular health company facing severe FDA compliance issues, including a corporate warning letter and multiple recalls, partnered with QualityHub to address urgent regulatory
Faced with a massive backlog of 30,000 complaint records and limited internal resources, a leading In-Vitro Diagnostics company partnered with QualityHub to regain compliance under
With the merger of BioAssist and QualityHub, BioAssist Founder and President Rebecca Fuller has become their newest Consulting Director.
Conducting effective remote audits require a good deal of organization both before and during the audit to ensure adequate preparation of the audit team, effective
QualityHub has a top-ranked team of experts that can guide your organization through the complexities of regulatory compliance, resolution of product problems and FDA remediation.
CAPA deficiencies are the most frequently cited issues in regulatory inspections, highlighting the critical role of a robust, well-documented CAPA system across all areas of
Plan and prepare for quality and compliance to drive customer satisfaction and business success with QualityHub.
QReview is QualityHub’s flexible, on-demand remote consulting and document review service, providing clients with rapid access to expert guidance across quality, regulatory, and validation challenges.
In this post, you’ll hear from our newest Consulting Director, Rebecca Fuller. With more than 30 years of industry experience, we wanted to get her
QualityHub partnered with a major medical device company to develop and execute regulatory strategies addressing FDA consent decrees and recidivist warning letters, stabilizing and improving