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.
EU Qualified Person (QP) Services in Cell & Gene Therapy (CGT)
In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of...
HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA
Hitech Health's Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate's Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for...
Hitech Health Appoint Clare O’Sullivan as Global Head of Commercial
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head...
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