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Clinical Needs:
- Clinical Study
- Regulatory agency approval
- OUS and US clinical trials
- Manufacturing facility registration and approval (FDB, ISO)
Common Problems Encountered During the Clinical Stage:
- Lack in-house manufacturing capability
- Low volume forecasts makes it difficult to justify in-house manufacturing
Venture Manufacturing Solutions:
- Rapid turnkey clinical build
- Alternate manufacturing and testing facility
- Implement quality systems
- Oversee FDB registration process
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