Quality, Compliance and Audit

Kinexum helps clients in applying quality principles in GLP, GCP and cGMP systems, compliance and audit, including: 

  • Gap Analysis 
  • Systems designed for the appropriate level of development of emerging companies  
  • Training and Review of GLP in research stage organizations and bridging to regulatory submission-grade documentation 
  • In person and virtual Clinical and Manufacturing QA Audits 
  • Clinical investigator and manufacturing site audits and regulatory inspection preparation 
  • 3rd party service provider (vendor) assessment and selection 
  • Standard Operating Procedure – Authoring, Training, and Review 
  • Project management, trial monitoring, QC of documents and Data management (CRF development, review of data management plans, edit checks) 
  • Temperature excursion review and analysis