Phase II clinical development
Advancing Process and Data Toward Commercial Readiness
We help you strengthen your manufacturing and analytical foundations, building the process understanding, data integrity, and technical control needed to move to late-stage development and commercial readiness.
- Overview
- How we support you
- Our core capabilities
- Our therapeutic modalities
- What this stage enables for your programme
- Why it's different working with us
- In our own words
Early development proves a concept but once you move to Phases I and II you need to show it can deliver. As your program matures, so must your process, analytics, and documentation.
We help you transition your program to reliability — transforming early-stage chemistry into robust, well-understood processes ready for validation and scale.
Whether you’re refining synthetic routes, enhancing control strategies, or optimising solid forms and formulations, we provide the expertise to meet both project goals and regulatory expectations, giving you confidence in every batch and every data point.
Our Core, Phase II Capabilities
• Model-led optimisation and process definition
• Design of experiments (DoE) and statistical analysis
• Green chemistry integration for yield and efficiency
• Demonstration batches to prove reproducibility and control
• Method development, optimisation, and qualification aligned with ICH Q14
• Impurity profiling, forced degradation, and trace-level analysis
• Stability studies and shelf-life justification
• Analytical tech transfer to GMP sites
• Crystallisation development and control strategy definition
• Polymorph and salt screening
• Filtration, washing, and drying optimisation
• QbD-driven process robustness and control
• Tech transfer packages and process knowledge documentation
• Risk assessment and deviation mitigation strategies
• Late-stage scale-up and sustainability evaluation
• Collaboration with CDMOs and CMOs for successful validation and handover
What This Stage Enables for Your Programme
We help you move through Phase II with confidence in your process, your data, and your readiness for the next stage.
Our work ensures the science behind your molecule can support the next level of scale, compliance, and consistency to transition seamlessly to Phase III or commercial scale.
Why It’s Different Working With Us
