Koch Consulting provides access to a highly diverse and cross-functional experienced consultants experienced in GMP and GDP, QMS and Validation.
• GMP and GDP
• Project Management. Leadership
• Quality Management System (QMS) and IT QMS
• IT Compliance and Security
• Data integrity program
• Validation and Periodic review
• Continuous improvement program
• Process optimization
• Veeva Vault, Veeva RIM
• Distribution and Supply chain Management
• Change Control
• Deviations, CAPA
• Complaints
• External and Internal Audit
• Collaboration with CMO and CRO
• Medical affairs, communication with healthcare providers
• CTPAT (USA) or AEO (Europe)
• Performing in-house and online GMP and GDP training and coaching of the technical and academic staff.