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:
- Warehousing.
- 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.
HiTech Health Authorised by the MHRA to Perform Batch Importation and Certification of Investigational Medicinal Products (IMPs)
HiTech Health today announced that the company has been granted a Manufacturer’s/Importation Authorisation (MIA) for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA). The company is now authorised to perform...
Cell Therapy: Points to Consider When Choosing a CDMO
At the Advanced Therapies Congress 2024 in London, Amina Al-Mossawi, a Qualified Person (QP) at Hitech Health, delivered vital insights on the crucial considerations for biotech firms when selecting a Contract Development and Manufacturing Organisation (CDMO). With...
Accelerating Regenerative Medicine : CCRM Australia and HiTech Health Announce Strategic Partnership
Hitech Health is delighted to announce its latest partnership with CCRM Australia, a not-for-profit organisation supporting regenerative medicine commercialisation in the Australian market. CCRM Australia works to accelerate the commercialisation of regenerative...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
Contact us
Get in touch anytime – we are always available to discuss your upcoming projects.