HalioDx provides professional framework
for IVD assay development with diagnostics companies,
for CTA and CDX with pharma companies
Our capabilities cover development, manufacturing, life cycle management, regulatory and marketing support and commercialization.
Pharma Services
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
Key features
- Project core team including IVD experts to match customer requests and needs
- A mature and efficient Design Control process (ISO 13485, ISO 9001, 21 CFR part 820)
- An International regulatory expertise and track record (CLIA, CE Mark, FDA 510(k) de novo and PMA, MLHW, CFDA)
- A wide range of technologies (IHC, Digital Pathology, QPCR, NGS)
