Tech Transfer & Operational Readiness
A new product introduction is expensive and highly pressured project. Shortening the time to market is key and therefore a right first-time approach is required. Our experience will ensure that the process development, transfer, execution, validation and filing of your process & product are undertaken effectively and efficiently.
Combination teams of our Project managers, C&Q experts, Quality & Compliance and Tech Transfer specialists ensure a holistic view across the program of deliverables, which reduces risk and delivers schedule certainty.
Achieving sustainability and reproducibility is also critical. Our experience in operational readiness ensures that all the supplemental programs that contribute to continued successful production are in place.
KPC International possess expertise in, but are not limited to:
- Strategy definition and schedule build
- Tech Transfer Project management
- Product Lifecycle Management (ICH Q8/9/10)
- Control Strategy
- Process Mapping
- Change Management
- Supply Chain systems
- Health and Safety
- Risk Assessment
- Cleaning Validation
- Process Evaluation
- Process Validation & CPV
- Regulatory Submission
- Shipping Validation
- Spare Parts management
- Maintenance & Calibration programs