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.
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).
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...
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...
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...
Stay Up To Date
Connect with us to receive the latest HiTech Health and industry updates.