Animal Health APIs
Pharmatory has a long history of working with animal health APIs, and is one of the leading European custom manufacturers in this field.
Synthetic development
- Route scouting
- Feasibility studies
- Development of synthetic routes
- Development of analytical methods
- Metabolite synthesis
- Preparation of standards / reference substances
- Impurity profiling and synthesis
Process R&D
- Process method development & validation
- Design of experiments (DoE)
- Process scale up
- Process development
- Process optimisation
- Identification of critical process parameters
GMP Manufacturing and Analytical Services
- cGMP manufacturing of APIs and key intermediates
- Process validations
- Analytical method evaluation
- ICH stability studies
- Degradation studies
- Process and technology transfers
- Validation transfers
Radiolabelling
- Route development for isotope labelling
- Synthesis of stable and radioactive labelled substances
- cGMP isotope labelling
Regulatory Support
- Full CMC package
- Drug master files
- Comprehensive reporting
