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. With a focus on technology transfer, our right-first-time approach expedites time to market.
From process development to filing, our experienced team ensures effective and efficient execution. Our collaborative Project Managers, C&Q experts, Quality & Compliance, and Technology Transfer specialists offer a holistic perspective, reducing risks and ensuring schedule certainty.
Beyond introduction, our experience in operational readiness ensures that all the supplemental programs that contribute to continued successful production are in place.
Read some of our tech transfer case studies here.
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