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.
Afortiori Development and HiTech Health Forge an Important Collaboration
Afortiori Development and HiTech Health Forge an Important Collaboration to Support the Clinical Research and Product Development of Groundbreaking Cell and Gene Therapies. Galway, November 9, 2023 - Afortiori Development, a premier full-service Clinical Research...
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...
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IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
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