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.
Understanding the New EU Clinical Trial Regulation (CTR)
On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and...
Cell and Gene Therapies: 3 Key Supply Considerations
Personalised medicines involve an increased degree of complexity when it comes to manufacturing and supply in comparison to traditional pharmaceuticals. The Horizon 2020 Advisory Group defines personalised medicine as 'a medical model using the characterisation of...
EMA Regulation of Cell and Gene Therapies (CGTs)
Cell and Gene Therapy products and other Advanced Therapy Medicinal Products (ATMPs) have to comply with European Medicines Agency (EMA) legislation at different stages of the development process, including Good clinical practice (GCP), Good manufacturing practice...
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UK: +44-20-30267419
US: +1-857-3265835
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