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.
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...
PMTC Spotlight – HiTech Health
HiTech Health is delighted to be selected as the 'Spotlight' company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight. HiTech Health is a full-service Contract Development and Manufacturing...
Good Distribution Practice (GDP): 3 Considerations for Ensuring Compliance
Ensuring product quality and integrity is maintained throughout the end-to-end supply chain of medicinal products is imperative. The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities...
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Get in touch anytime – we are always available to discuss your upcoming projects.