Process Optimization
- Production planning
- Inventory management
- Distribution channel
- Business and process strategy
- Engineering problems
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Market Entry Strategies
- Pricing strategies
- New product/technology introduction & analysis
- Market research and competitor analysis
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Cleanroom Consulting
- Contamination control & cGMP audits
- New cleanroom product introductions
- Cleanroom designs & applications engineering
- Process isolation, environments & troubleshooting
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Regulatory
- FDA & foreign regulatory authority interactions
- Approval pathway strategy
- cGMP issue resolution
- Product development & approval strategy planning
- Pre-IND/IDE & Pre-BLA/PMA
- Preclinical program design
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Strategic Planning and Acquisition Analysis
- Strategic cost management
- Implementation planning/management
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Business Development/New Products
- Product cost accounting
- New indications for “old” products
- Process development/management
- Facility design & approval
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Cell/Gene Therapy
- Complete supply chain planning & development
- Cell harvesting, manufacturing & infusion
- Positioning for the next generation of blood products/services and/or transfusion medicine
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Production Planning and Inventory Management
- Distributor and channel management
- Production processes to maximize flow and flexibility
- Streamlining supply chain systems for higher services and inventory turnover
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Scientific/Medical Monitoring and Reviews
- Scientific/technical evaluations & recommendations for market opportunity
- Competitive technology analysis
- Product bioprocessing assessment & recommendations to reduce development time
- Assessment & strategic recommendations on cGMP manufacturing options
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Interim Management
- Immediate qualified assistance with specific projects or directly manage functional areas
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