Assay Development Services

with a partner who masters IVD from concept to market

From Clinical trial assay to Single Site PMA development and commercialization

Pharma

Diagnostics

Clinical Trials Assays & CDX

HalioDx helps your clinical development team to discover and validate new biomarkers by providing a comprehensive analysis of key elements of the immune contexture, in condition of use of your drug, in the targeted indication during your exploratory work.

When a biomarker is identified as potentially clinically relevant, HalioDx is your partner of choice to start a feasibility work and to develop a Clinical Trial Assay (CTA) under Design Control.

Within its 2 CLIA laboratories HalioDx can test patients’ samples using validated CTAs during the clinical phases.

As a next step, if applicable, HalioDx will develop a single site PMA leveraging its IVD Assay Development capabilities & expertise.

Assay Development

HalioDx provides flexible framework for IVD assay development for diagnostics and pharma companies, technology providers and clinical labs. Our offer is an integrated approach to IVD markets and covers contract development, manufacturing & supply, life cycle management and commercialization.

We integrate all essentials requirements in our project core teams:

  • Involvement of IVD experts at inception and all along the project to make sure that all prerequisites are covered, monitored and aligned with our partner objectives.
  • A mature and efficient Design Control process ISO 13485 & ISO 9001 certified and in compliance with 21 CFR part 820.
  • A milestone-based structure, enabling transparent projects monitoring by joint steering committee during the development.

Multiple registrations & launches have been successfully achieved these past years demonstrating superior quality of services.

 

Modularity & Customization "Tailor Made Project":

  • PMA & 510( k), CE- IVD, RUO, CTA, CDx development
  • Project recast for compliance with IVD-R
  • Multisite collaboration
  • Patient samples procurement
  • Multi technology development (NGS, qPCR, IHC, ….)
  • Development under HalioDx Design Control SOPs or third party Design Control SOPs
  • Design control compliant to new European regulation
  • Fully integrated manufacturing unit to allow optimized time to market

HalioDx provides you IVD commercialization under your brand.

 

 

Learning more on our Assay Development Services ? Contact us

 

 

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