This document outlines a stability program to ensure drug product quality over time. It covers method validation, protocol development, shelf-life determination, and ongoing monitoring, following
A global biotechnology leader partnered with QualityHub to conduct thorough third-party audits across its facilities, suppliers, and R&D sites, ensuring rigorous compliance and risk management.
QualityHub partnered with a global pharmaceutical and medical device company to transform a reactive CAPA system into a proactive, cross-functional process aligned with FDA expectations.
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.