Case Study Overview
Successful QMS implementation for a clinical-stage biotech is one of the most critical steps when preparing for Phase III and commercialization. Without a scalable Quality Management System, compliance risks and inspection findings can delay timelines and damage investor confidence. This case study shows how GMP Bridge supported a U.S.-based biotech in designing and implementing a fit-for-purpose QMS aligned with FDA and EU GMP standards.
The Challenge
A clinical-stage biotech in the U.S. preparing for late-phase trials and commercialization lacked a fit-for-purpose Quality Management System (QMS). Existing processes, designed for early clinical development, were fragmented and insufficient for commercial GMP standards, posing significant inspection and audit risks.
