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

Inception

Development

Clinical

Manufacturing