Preparing for Commercial Production -
Minimize the Unexpected

Augment your organization with our insight and industry experience. The Tamarack Group assists with client awareness of current regulatory expectations for manufacturing operations, and helps with pre-production activities, such as-

• Facility design and qualification
• Laboratory qualification
• CMO/supplier requirements, qualifications, contracts
• Vendor / supplier audits
• Contamination control and environmental monitoring programs
• Process scale-up and pilot plant qualification
• Process and method qualification & validation
• Design / technology transfer planning
• Master batch record / device master record design
• Quality agreement development
• Quality Management /GMP System design and Quality Manual writing
• Process risk assessments and critical control points identification

The Tamarack Group consultants increase your institutional knowledge and readiness for commercial production and market introduction.

See our books on Validation and Risk Management !!