Selecting a CDMO for Preclinical Drug Development

Selecting a CDMO for Preclinical Drug Development

Early-Stage Considerations

Preclinical development has unique requirements that differ from later stages.

Key Selection Criteria

Scientific Expertise

• Process development capabilities
• Formulation expertise
• Analytical method development

Flexibility

• Small batch capabilities
• Rapid turnaround times
• Willingness to iterate

Regulatory Knowledge

• IND-enabling experience
• GLP compliance
• Documentation standards

Evaluation Process

1. Technical assessment
2. Capacity evaluation
3. Team assessment
4. Reference checks

Common Pitfalls

• Over-engineering for the stage
• Insufficient documentation
• Poor scalability planning