Product Quality Alliance

Product Quality Alliance

Product Quality Alliance is committed to providing product quality consulting for analytical development, QC testing and GMP manufacturing of pharmaceutical and biopharmaceutical products and devices. They have extensive CMC experience in product development from early stage through commercialization and beyond.

Product Quality Alliance is a consulting team based in Southern California. They are experienced at supporting small companies that are challenged with managing the “Cost of Quality.” The company ensures product quality and decreases costs by reducing failures, defects, and rework.

The majority of their services can be provided remotely at a greatly reduced rate.

Analytical & Quality Control:
  • Analytical development and optimization
  • Method transfer, qualification and validation
  • Product characterization
  • Stability protocol development and data analysis
  • API product and in-process specification development
  • Contract Testing Laboratories (CTL) liaison
Quality Assurance:
  • SOP/Mfg procedure development, review, and training
  • Batch Record review
  • Change control management and support
  • NC/CAPA management and support
  • Technical investigations and writing
  • Regulatory inspection support
  • Vendor/supplier qualification
  • Validation review
  • CMC review/development
  • Contract Manufacturing Organization (CMO) liaison
  • Project management
Quality Systems:

Utilizing a combination of Lean and Six Sigma principles and tools, they help you build, improve and implement a more efficient Quality System that ensures a successful manufacturing process.

To learn more click here.