Katana Consulting

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Katana Consulting

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Quality and Regulatory Affairs Services

Quality Assurance

Meeting your strategic goals and global regulatory compliance effectively, with a strong focus on AI readiness and deployment

Inspection Readiness

Prepare your firm for inspections or audits. Critical as the FDA ramps up deployment of Elsa AI

AI Readiness

Four-week diagnostic of your Q & R processes, and how best to apply AI to improve readiness

Operational Quality

Manufacturing transfers / Factory optimization 

QMS Transformation

Restructure and optimize your Quality Management System

Remediation

Address cited gaps or potential concerns for any elements

Leadership

Interim Quality Leader


Regulatory Affairs

Bringing your products to global markets

Regulatory Strategy

Establish the most effective strategy based on your targeted markets 

Leadership

Interim Regulatory Affairs Leader 

Market Submissions

Develop submission content and packages to enable clearance 


Operational Excellence

Optimizing processes to increase customer satisfaction and your firm's profitability

Lean Six Sigma Transformation

Optimize your firm's capabilities to increase productivity and quality 

Quality Culture and Training

Build capabilities within your organization by training and developing your leaders and employees   

Financial Services

Financial modeling, business cases and FP&A support

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