OVERVIEW
At whatever stage Alphora services are applied, it is with a view of the long term scale up and commercialization of the Active Pharmaceutical Ingredient. At all stages of development, Alphora will consider issues related to:
- Development of New Synthetic Routes
- Identification of Strategic Intermediates as Candidates
for non-GMP Outsourcing
- Process Optimization
- Process Validation
- Raw Material Costs and Commercial Sources
- Related Compounds and Potential Impurities
- API Physiochemical Properties (Salt Selection and Polymorphism Studies)
- Final Isolations and Methods
- Analytical Method Development and Validation
- Specification Development
- Stability of the Final Compound and Intermediates
….. providing the Right Development at the Right Time
