Project and Supply Chain Management
HiTech Health provides end-to-end project and supply chain management solutions, supporting your products throughout the lifecycle while safeguarding high quality and compliance. We can support your pipeline of clinical therapies through to commercial launch in the EU, UK and Rest of World (RoW) markets.
End-to-End Project Management
Our project management team can help you effectively manage activities from preclinical development through to commercial launch and supply. You can rely on us to track and monitor key development and manufacturing activities through regulatory filing and launch.
- Overall project planning and management of products.
- Oversight of planning, preparation, and submission of the application dossier (E.g. IMPD, IND, CTA, NDA, MAA) with all required competent authorities.
- Dedicated project management resource that will act as an extension to your internal team and work closely with your providers of raw materials, drug substance, drug product, analytical testing to ensure they are aligned.
- Extensive expertise with time and temperature-sensitive advanced therapies including cell and gene therapies.
Working closely with your internal team, HiTech Health can assist with ensuring key milestones are met.
Supply Chain Management
HiTech Health have the experts and knowledge to help with end-to-end supply chain management. Some of our expertise includes:
- Our team can oversee supply from raw materials right through to distribution.
- Manage your day-to-day supply chain needs including material procurement, arranging temperature-controlled transportation and storage.
- Responsible Person (RP) services to ensure your supply chain is compliant with current Good Distribution Practice (cGDP).
- Risk assessment and mitigation strategies.
- Support with obtaining a Wholesale Distribution Authorisation (WDA) in the EU or UK
- Resource and capacity planning.
HiTech Health can help with developing and managing a robust supply chain that meets your needs.