Startup and emerging life sciences companies often do not have a mature and complete quality management system in place for their commercialization activities.
A strategic QMS framework will reinforce a company's quality goals by implementing a governance structure and operational and procedural practices in support of product commercialization. This case study shares how USDM helped a pre-commercial company to enhance and harmonize, its QMS to prepare for an upcoming pre-approval inspection (PAI) and meet its regulatory compliance objectives.
- An emerging biotechnology and pharmaceutical company with ~200 employees
- In their pre-commercial, phase-3, late-stage clinical drug trials
- The customer needed assistance identifying gaps and developing an implementation roadmap for their Quality Management System (QMS)
- The roadmap defined a deployment schedule and the new GxP capabilities needing to be implemented within their QMS to prepare for commercialization
- A strict deadline for a pre-approval inspection (PAI) was scheduled with the regulatory authority, and the customer needed a high-performance team and professional project management to accelerate the timeline
- The project required the coordination of a large multi-functional team requiring alignment from all stakeholders to support the implementation of the new QMS
- The customer required a cGMP training program to get the organization up to speed on the latest regulatory requirements