Supply Chain
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.
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New FDA ‘Super Office’ created for Cell and Gene Therapy Products
The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in...
Importation of Medicinal Products: Understanding the EU requirements
The manufacturing of medicinal products for the EU market frequently occurs outside the EU zone and this presents logistics and regulatory considerations for the product owner. All stages of manufacturing medicinal products in third countries should be carried out in...
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