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).
Temperature Controlled Transportation of Medicinal Products
Temperature is a critical parameter in the transportation and storage of medicinal products. The temperature must be controlled and monitored from the manufacturing site through to the distributor and site of medicine use. When temperatures go outside the specified...
Five Key Considerations When Selecting a Cell and Gene Therapy CDMO
Many Cell and Gene Therapy (CGT) companies outsource product development and manufacturing activities to a Contract Development and Manufacturing Organisation (CDMO). It is critical to ensure that an informed decision is made when selecting a CDMO to prevent future...
HiTech Health Authorised by the MHRA to Perform Batch Importation and Certification of Investigational Medicinal Products (IMPs)
HiTech Health today announced that the company has been granted a Manufacturer’s/Importation Authorisation (MIA) for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA). The company is now authorised to perform...
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