CBE’s focus is on Technical and Scientific due diligence and aims to ensure the company’s technologies, facilities, manufacturing processes, quality systems and R&D portfolio are aligned with commercial forecasts and assumptions.
- Quality Systems, GMP, GLP compliance assessments
- Manufacturing processes and improvement plans
- COGs analysis
- Facility design
- Regulatory status
- R&D portfolio
- Key risks and risk mitigation strategies
- Prior art reviews assessing freedom to operate, and/or ability to license out technologies, or need to license in technology, to operate successfully.