Assessment for CGT
Cell and gene therapies are distinctly different from traditional biopharma product and their supply chains require uniquely designed logistics solutions for optimal patient delivery and administration.
Helping you address complex supply chain challenges
Materials produced for autologous and allogeneic therapies must be shipped under strict temperature controls within extremely tight timelines, and with full traceability always. HiTech Health can help you address complex supply chain challenges and provide end-to-end assistance with managing all aspects to ensure the products are manufactured and supplied to patients efficiently and effectively.
HiTech Health can assist you with:
- Day-to-day management of supply chain activities.
- Coordination between CMOs, treatment centres and logistics providers.
- Supply chain risk assessments and mitigation plans.
- Selection of supply chain vendors.
- Evaluation of CGT supply chain and improvements.
- Responsible Person (RP) services for CGT.
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...
Hitech Health Appoint Clare O’Sullivan as Global Head of Commercial
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head...
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