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