Due to the time or budget constraints, process development is often underestimated at the early development phases, slowing down and jeopardizing high-value projects. At SpiroChem, thanks to our in-depth understanding of drug development challenges, we recommend and offer Early Route Scouting that guarantees smoother, safer, faster and more cost-effective scale-up from pre-clinical studies, paving the way for clinical development and market.
Classical way with short-term benefits
The MedChem route:
- is never really questioned
- is felt to be fit-for-purpose and developing it to be a lower risk
The short-term benefits:
- consist of putting just about enough FTEs for quick fixes
- don’t preclude longer term risks at the most time-critical part
of your clinical development
Do you want to avoid:
- supply delays at the most time-critical stage of your clinical development?
- refiling for regulatory submissions because of a necessary late-stage
synthetic route change?
The way to go with long-term benefits
The earlier a robust route is designed and developed, the shorter the overall time and the lesser the investments until process validation and registration.
SpiroChem helps you to be prepared to ensure:
- Smooth scale-up from GLP-Tox batches to GMP batches
- No disruptions from discovery to market
