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Quality Assurance and Control

Kinexum can help you develop quality assurance and control systems to ensure that you conform to Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and clinical Good Manufacturing Practice (cGMP). We can also help you audit these systems as needed.

Our services include:

  • Gap analysis  
  • Authoring, training, and review of standard operating procedures 
  • Creation and implementation of systems for emerging companies 
  • GLP training and review in research-stage organizations and transition to regulatory submission-grade documentation  
  • In-person and virtual clinical site and manufacturing QA audits  
  • Regulatory inspection preparation  
  • Third party service provider (vendor) assessment and selection  
  • Project management, trial monitoring, QC of documents, and data management (CRF development, review of data management plans, and edit checks)  
  • Temperature excursion review and analysis