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).
Cell and Gene Therapy Manufacturing
HiTech Health are delighted to have an article entitled 'Cell and Gene Therapy Manufacturing Considerations for Early Stage Companies' published in distinguished publications, cellandgene.com and outsourcedpharma.com. The article should be of benefit to companies who...
2024 ATMP Review
Over the past decade, the regenerative medicine landscape has undergone an extraordinary evolution with the continuous growth of Advanced Therapeutic Medicinal Products (ATMPs). ATMPs are medicines for human use that are based on genes, tissues or cells. They treat...
Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy
IDA Ireland, the agency responsible for the attraction and retention of inward foreign direct investment (FDI) into Ireland, has recently published an article entitled ‘Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy’. Hitech...
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Get in touch anytime – we are always available to discuss your upcoming projects.