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
