Tech Transfer, Scale-Up and NPI
HiTech Health’s cross-functional expertise and dynamic team of consultants can assist with all aspects of the technology transfer and process scale-up to full GMP 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 development through to GMP manufacturing and successful product launch. We can help with the introduction of a new product or process to a site including:
- Implementing structures and processes in place for successful product introduction
- Team building and knowledge retention
- Project management and milestone tracking
- Site readiness and gap analysis
- Timelines and metrics
Including other areas often overlooked, such as:
- Warehousing and storage capacity
- Packaging and labelling activities
- Serialization readiness and compliance with Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act
Technology Transfer (TT) and Process 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.
Speak with our team today to find out how we can support your technology transfer and process scale up activities.