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GxP QMS Framework Prepares Emerging Biopharma for Commercialization


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.


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