BAI's Manufacturing and Quality Assurance excellence support can be focused in discrete technical areas like validation, stability programs, process analytical technology, sterility assurance, particle burden control, visual inspection or broader programs to support growing and changing businesses, including regulatory compliance inspection preparation and drug/device application (CMC) preparation for US/FDA, European Union, and Asian markets, planning and management of Electronic Batch Record integration, SAP integration, integrated information management system strategy and implementation.
We also provide Change Management and Transitional Leadership that can rapidly and effectively change direction in existing organizations to improve product quality and compliance, efficiency and business results. Whether we participate directly in the change process through filling transitional key management roles and managing daily business, or whether we coach associates, managers, and senior managers in their daily jobs, we know what it takes to optimize systems and processes, and to get people to change how they think, act, and make sound decisions.