The USDM Commercialization QMS Framework is a top-down solution that is designed to reinforce a company's quality goals by implementing a governance structure with the supporting operational and procedural practices.
It can help a company align its overall quality mission, with its quality objectives and organizational roles and responsibilities. The QMS framework will promote a clear delineation of operational boundaries from a regulatory and quality perspective. A global QMS program must provide a platform for the implementation of an effective organizational governance structure that will support a company's long-term healthy growth.
USDM's Commercialization QMS Framework
- Provides a comprehensive framework for a startup life sciences company
- Ensures an implementation that compliments your existing QMS program and fills any gaps
- Complies with US Food and Drug Administration cGMP regulations and other global regulatory authorities including, the European Medicines Agency, Health Canada, Japan's Pharmaceuticals and Medical Devices Agency, and the UK's Medicines and Healthcare Products Regulatory Agency and more
- Harmonizes and integrates USDM's QMS framework into your existing policies and procedures by partnering with your company's Quality Assurance and Regulatory Affairs teams to achieve your quality goals
Contact us to learn more.
Read our blog, SOPs 101 – A Best Practice Approach for Emerging Life Sciences Companies, to learn more about our work with startup life sciences companies.