Phase III process development and control
Proving Readiness for Commercial Scale
We help you define, demonstrate, and document control, aligning science, data, and strategy to achieve process validation and regulatory approval.
- 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
At Phase III, the goal shifts to validation. Every parameter, limit, and control strategy must be demonstrated, justified, and ready to withstand regulatory and commercial scrutiny.
We ensure that your process is not only efficient, but scientifically defensible – built on complete understanding, reproducible performance, and validated analytics.
We bring together process chemistry, analytical excellence, and data-driven governance to deliver a process that’s ready for technology transfer, validation, and commercial production. Our work strengthens the scientific foundation that underpins every successful registration and launch.
Our Core, Phase III Capabilities
• Design of experiments (DoE) and multivariate analysis for CPP confirmation
• Process reproducibility and validation batch execution
• Statistical evaluation of process capability and control limits
• Lifecycle management planning for continued verification
• Method validation, robustness, and transfer to commercial QC
• Reference standard qualification and impurity specification control
• Data integrity and traceability assurance
• Regulatory documentation and response support
• Preparation of process validation and tech transfer documentation
• GMP demonstration batches and comparability studies
• Collaboration with manufacturing partners to enable smooth validation runs
• Sustainability and continuous improvement recommendations for long-term control
• CMC authoring and validation documentation for NDA/MAA filings
• Preparation for pre-approval inspections and QA readiness reviews
• Risk-based justifications and CAPA frameworks
• Authority liaison and response strategy
What This Stage Enables for Your Programme
At this stage, your process becomes a validated system. Our integrated approach ensures it performs consistently and predictably, delivering compliant, reproducible results ready for commercial manufacture and inspection. With robust documentation and seamless technology transfer, you move forward knowing your CMC package can withstand the highest level of regulatory scrutiny.
Why It’s Different Working With Us
