Strategic partnership
with leading OEMs
Our expectation
Strategic partner for clinical approval and commercialization
Leading OEM or access to leading OEMs (converter) with strong market position and sales organization worldwide
Strategic partnership
Business model
New Co. (contract manufacturer)
Partner (legal manufacturer)
Pre-development
- Pre-development
- Technical feasibility
- Pre-clinical investigation
- Product specification
- Observation study
Development
- Quality assurance
- Up scaling / validation of production (GMP)
- Product concept freeze
- Clinical trials
- CE / FDA approval
Supply
- Supply agreement
- Regulatory compliance
(CE, FDA) - Quality system and control
(QS) - On-time delivery (SCM)
- Marketing & Sales
