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.
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...
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...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
Stay Up To Date
Connect with us to receive the latest HiTech Health and industry updates.