The Complete Guide to CDMO Selection

The Complete Guide to CDMO Selection

Selecting the right CDMO partner is one of the most critical decisions in drug development.

Key Selection Criteria

1. Technical Capabilities

• Manufacturing technology fit
• Scale-up experience
• Analytical capabilities

2. Quality & Compliance

• Regulatory track record
• FDA inspection history
• Quality systems maturity

3. Capacity & Flexibility

• Available capacity
• Lead times
• Ability to scale

4. Financial Stability

• Company financials
• Long-term viability

Evaluation Process

1. Define Requirements: Document your specific needs
2. Initial Screening: Create a shortlist
3. SmartRFI Process: Gather structured capability and fit information
4. Site Audits: Visit top candidates
5. Due Diligence: Financial and quality verification
6. Contract Negotiation: Terms and conditions