Almac Diagnostic Services is uniquely placed to partner with clients throughout the entire process of Companion Diagnostics (CDx) development.
From the fundamental research and discovery phase, to development and validation, conducting clinical trials and the manufacturing of test kits or lab developed tests, to patient sample testing. With expert supporting services teams in Design Control, Project Management, Data Sciences and Quality & Regulatory Affairs we ensure that your individual programme objectives are met on time, within budget and to high quality standards.
Almac Group has 50 years of manufacturing and global distribution experience to support your CDx commercialisation needs.
Almac Diagnostic Services commercialisation team will partner early with your commercial team to ensure your assay will be suitable for the target market. Our teams agree a joint commercialisation plan and work in partnership throughout the lifecycle of the product.
Almac Diagnostic Services can offer multiple flexible CDx commercialisation models for BioPharma clients to choose from: Single Site Model, IVD Kit Model or IVD Kit Hybrid model (with bridging).
Design Control & Risk Management
Assay Development & Validation
Assay Software Development
Single Site Test Capability
IVD Kit Manufacturing Capability
Regulatory Submissions in Multiple Territories