HalioDx provides professional framework for Clinical Trial Assay (CTA) and Companion Diagnostics (CDx) development.
It covers development, manufacturing, life cycle management, regulatory and marketing support and commercialization.
Thanks to its strong expertise and its compliant capabilities and processes, HalioDx successfully develops CDx tests eligible for a co-registration with the FDA and cover the whole drug development process with strong responsibilities :
- Biomarker discovery & Design Concept
- Assay Development (CTA)
- Proof of Concept
- Assay Validation
- Clinical trial
- PMA submission
- Post Launch
HalioDx all along the drug development process
A proven expertise to assist biopharma with innovative technologies and workflows
