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FDA 483 and other Health Authorities' Notices significantly burden pharmaceutical operations and business, and a transformative rapid improvement is required to maintain the position in the marketplace. Optimi Management Consulting has significant experience in setting up a remediaiton program and manage it to accelerate improvements while minimizing the cost.
Set quality strategy, align cross-functional leadership and set the roadmap.
Identify critical required capabilities and organiational model, build or acquire capabilities and organize for success
Establish goals that drive towards strategic goals and leadership accountability
Establish performance management capability and process to continuously monitor and improve performance
Ensure regulatory compliance with quality culture
Establish tools and processes to continuously optimize performance
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