Technical Due Diligence and Vendor Selection
HiTech Health can support you in ensuring you make the optimal decisions when it comes to technical due diligence and vendor selection.
Technical Due Diligence
It is critical to ensure that your CDMO partners have the right technical expertise to support the manufacturing and supply of your product. Key areas to assess include:
- Capacity analysis.
- Technical audits.
- Equipment and process line capability.
- Warehouse and storage capabilities.
- Technical resources.
Vendor Selection
Contracting your CDMOs and key suppliers requires both legal and technical expertise to ensure that these contracts meet your needs. We have the expertise and the business process knowledge to support you through the partner selection process.
HiTech Health can provide technical expertise to support your legal team with key contracting activities such as:
- Contract Manufacturing Organisations (CMOs).
- Analytical Laboratories.
- Logistics Providers.
- Contract Research Organisations (CROs).
- Supply Contracts.
- Master Service Agreements (MSAs).
- Quality Technical Agreements (QTAs).
EMA Regulation of Cell and Gene Therapies (CGTs)
Cell and Gene Therapy products and other Advanced Therapy Medicinal Products (ATMPs) have to comply with European Medicines Agency (EMA) legislation at different stages of the development process, including Good clinical practice (GCP), Good manufacturing practice...
Cell and Gene at the Abbey 2021 – Galway, Ireland
From 10th to 12th November, HiTech Health hosted ‘Cell and Gene at the Abbey’, a world-leading conference focusing on Production, Scale-up and Globalisation of cell and gene therapies. We would like to sincerely thank all the speakers, sponsors and attendees of this...
HiTech-Health awarded with government funding
HiTech Health awarded with €7m government funding for 'disruptive' project HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...
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