Complete CMC Consulting
Chemistry
- Process suitability and scalability
- Predicting bottlenecks at scale
- Bridging the gap between Q11 and your process
- Critical process parameters
- Impurities and degradation
- Stability
Manufacturing
- Scale-up and process adaptation
- Process validation
- Reaction and process safety
- OEL classification
- Cost competitiveness
- Avenues for cost reduction
Controls
- Compliance to Q7
- Devising specifications for Input, in-process and Output
- Cost controls
- Validations of Analytical methods
Documentation
- MBR
- BMR
- Process development report
- Standard testing procedures
- Product development report
- DMF compilation
- CMC section compilation