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
Require support with developing a robust supply chain for the GMP supply of your products? HiTech Health can help from strategic planning through ensuring a robust product supply.
EU and UK 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 the EU, UK, and RoW. We hold MIAs in both the EU (HPRA) and UK (MHRA).
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
From raw materials right through to finished product distribution, we can work with your team to select and contract the optimal partners for your product supply chain.
Project Management
We can provide Subject Matter Experts (SMEs) to support with the development of products through regulatory filing and launch. Our team’s experience ranges from small molecule products through to complex cell and gene therapies.
Technical Transfer, Scale Up & NPI
Process development from laboratory through process scale up and GMP manufacturing is a complex process. HiTech Health can assist from planning through execution.