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.
The Situation
- 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
The Solution
- USDM was selected for the project because of the expertise of our consultants and our extensive life sciences domain experience
- USDM performed a gap assessment of the customer's existing QMS
- USDM created and implemented a strategic roadmap to remediate the QMS gaps identified
- USDM's senior program manager created a detailed timeline to ensure that the remediation of the customer's QMS was delivered ahead of schedule and without delays
- USDM conducted the remediation and facilitated the communication and collaboration between all stakeholders to gain alignment and complete the required deliverables
- USDM drafted 50+ SOPs and integrated the new policies and procedures within the customer's existing QMS
- USDM developed and delivered a cGMP training curriculum program enabling the customer to educate and achieve their quality requirements
The Results
- Less than 6 months to remediate the customer’s QMS
- 50+ new SOPs delivered
- PAI deadline achieved to meet regulatory requirements
Learn more about USDM's commercialization QMS framework.