Services

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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