Our API services include:
- Route-scouting
- Reaction optimisation
- Synthesis and characterisation of impurities
- Characterisation (eg. NMR, IR, optical rotation, mass spectroscopy)
- Setting of specifications
- Development services based on ICH Q11 guidelines
- M7 assessment based on QSAR reports
- Nitrosamine risk assessment
- Strategies for analysing residual solvents, elemental impurities and genotoxic impurities
- Stress studies
- Stability studies
- Accelerated stability studies
- Polymorphism
- Hygroscopicity
- Physicochemical properties (eg. Melting point, boiling point, solubility, particle size, bulk and tapped density)
New molecule development
- CRAMS (Contract Research and Manufacturing Service)
- Synthesis of compound libraries
- Synthesis of impurities
- Selection of candidate molecule(s)
- Scale-up for early pre-clinical development
- Scale-up for first-in-man studies
Sourcing of APIs and intermediates
- With our global network, we can source intermediates and raw materials necessary for your API synthesis industry. We partner directly with the manufacturers and can supply you with high quality synthetic intermediates at competitive prices.
- We can also source high quality cGMP API materials to meet you specifications. We can also help you to identify and qualify alternative sources of APIs to avoid shortages. Our partners can offer high quality APIs at very competitive prices.