Partnering with City Lights Ministry for Hurricane Helene
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An overarching quality management system creates an infrastructure, embedding quality throughout every aspect of drug manufacturing. Developed in tandem with the manufacturing processes, it includes detailed procedures, explicit training, and above all, an inherent expectation of quality.
Carefully crafted policies and standard operating procedures (SOPs) serve two purposes: to satisfy regulatory authorities, and ultimately to ensure the safety of your product. From documentation hierarchy to change controls, training to NC/CAPA programs, we can develop your quality management strategy, then ensure it is correctly implemented.
The path to market is full of inspections, from the health authority to regulatory authorities. With the right quality systems in place, you never have to worry. Precision accountability often extends to the pre-approval inspection; we always stand ready to defend the work we implement.
Quality Program Support
Quality Management Systems
Data Integrity Part-11 Compliance
Regulatory & Compliance
Our expertise in quality is grounded in practice. In countries around the world, we have led, launched, managed, and maintained the most complex drug manufacturing facilities. We know where potential issues lie—and how to effectively avoid them.
Our greatest resource is our people, with patients at the core of everything we do. Commitment to that value provides a foundation of success for us and our partners.