Tech Transfer, Scale-Up and NPI
HiTech Health’s cross-functional expertise and dynamic team of consultants can assist with all aspects of the scale-up process to full commercial production. We place a strong emphasis on ensuring product supply is robust, high quality and cost effective.
New Product Introduction
HiTech Health has experience with all aspects of product development from pre-clinical through launch. We can help with the introduction of a new product or process to a site including:
- Structure and processes in place for successful product introduction.
- Team building.
- Project management.
- Site readiness and gap analysis.
- Timelines and metrics.
Including other areas often overlooked, such as:
- Packaging activities.
- Serialisation readiness.
Technical Transfer (TT) and Scale up
There are many process transfers during the lifecycle of products from R&D to pilot facilities and ultimately commercial scale GMP manufacturing.
We can help you ensure success with your technical transfer/process scale up including:
- Project manage the scale up and transfer of new and existing products, both to internal and external sites.
- Selecting the right partners such as manufacturing, analytical and packaging providers.
- Technical transfer planning and documentation.
- Validation master plans.
- Document templates and reports.
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