Product Development, Launch & Supply
Are you developing new medicinal products with the ultimate goal of market approval and supply to patients? Why not contact HiTech Health and use our experts to help develop, scale up, launch and supply your new products? We have the experts and can save you time and money in the development of your products in this highly regulated and complex business.
Product Development, Launch & Supply
Are you developing new medicinal products with the ultimate goal of market approval and supply to patients? Why not contact HiTech Health and use our experts to help develop, scale up, launch and supply your new products? We have the experts and can save you time and money in the development of your products in this highly regulated and complex business.
Strategy and Supply Chain
Need help with developing a supply chain for the GMP supply of your products? HiTech Health can help from strategic planning through ensuring a robust product supply.
EU QP Services
Our Qualified Persons (QPs) can offer expert quality support to your company to successfully release your product to clinical trials or to market in both EU, UK, and RoW.
Regulatory & Compliance
HiTech Health’s experienced and diverse team can support you to meet all your regulatory and compliance requirements, from strategy and planning to dossier writing and submission.
Technical Due Diligence and Vendor Selection
Need to find the right GMP suppliers including CDMOs, warehousing and analytical laboratories?
Project Management
Need experts and processes to help with the development of products through regulatory filing and launch.
Technical Transfer, Scale Up & NPI
Process development from laboratory through scale up and GMP manufacturing is a complex process. HiTech Health can assist from planning through execution.
Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy
IDA Ireland, the agency responsible for the attraction and retention of inward foreign direct investment (FDI) into Ireland, has recently published an article entitled ‘Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy’. Hitech...
Temperature Controlled Transportation of Medicinal Products
Temperature is a critical parameter in the transportation and storage of medicinal products. The temperature must be controlled and monitored from the manufacturing site through to the distributor and site of medicine use. When temperatures go outside the specified...
Five Key Considerations When Selecting a Cell and Gene Therapy CDMO
Many Cell and Gene Therapy (CGT) companies outsource product development and manufacturing activities to a Contract Development and Manufacturing Organisation (CDMO). It is critical to ensure that an informed decision is made when selecting a CDMO to prevent future...
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UK: +44-20-30267419
US: +1-857-3265835
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