Capability
Development, Scale-Up, and Transfer
Our R&D and tech transfer teams design robust processes, validate critical parameters, and deliver comprehensive documentation for global commercialization.
QbD
Design of Experiments to define CQAs & CPPs
Validation
Process, cleaning, and analytical validation
Tech Transfer
Structured protocols and knowledge transfer
Documentation
Complete batch records and regulatory support
How We Partner
- Feasibility & screening: Rapid assessment of formulation and process options
- Process design: DoE-driven optimization and scale-down/scale-up modeling
- Risk management: FMEA and control strategies to assure robustness
- Regulatory readiness: Data packages supporting filings and audits
Global Transfer Support
- Site alignment: Equipment mapping, SOP harmonization, and training
- Performance qualification: PPQ protocols with clear acceptance criteria
- Lifecycle management: Continuous improvement and change control
- Supply assurance: Bridging strategies to maintain market supply