Eristavi Consulting will provide consultants with specific expertise and technical skillset that is not currently available at your company or is not needed on a full time, long term basis:
• Support site selection activities
• Internal and External Audit support
• Lead GMP commissioning efforts in line with the CMO's life cycle
• Identify, develop and track performance metrics to effectively monitor laboratory performance and customer support
• Vendor qualification and inspection of suppliers
• Contract Manufacturing and Laboratories Methods Qualification
Assist with quality processes:
• Write SOP’s
• Perform vendor audits
• Reviewing trend limits for QC Laboratory
• Preparing service contract agreements and vendor qualification
• Providing QC laboratory support
• Vendor qualification and inspection of suppliers
• Develop, implement, and improve quality programs to meet worldwide standards for safety, efficacy, and quality
Provide assistance to:
• Identify, audit, recommend and manage contract manufacturing organizations (CMO’s) for all Drug Product commercial tasks.
• Commercial QC Laboratory Design
• Manage Method Transfer Activities
• Stability Study Program Design
• Lead GMP commissioning efforts in Line with the CMO Life cycle
• Identify and recommend CMO's based on general client requirements
• Manage CMO's on behalf of the client to achieve the desired outcome and deliverable
• Drafting, negotiating and finalizing Quality Agreements and Laboratory service agreements with Licensees, Contracted QC Labs and Logistic Service Providers