Companion diagnostics are now central to precision medicine and targeted therapies. Yet many CDx programs struggle—not because of weak science, but because of misaligned clinical, regulatory, and lifecycle strategy.

Global CDx development requires tight drug–diagnostic co-development, PMA-level evidence in the US, dual oversight under EU IVDR, planning for limited biomarker-positive populations, and lifecycle performance obligations beyond approval.

Without early alignment, CDx programs often face delays, re-work, or restricted labeling.

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Where CDx Programs Commonly Break Down

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   • Clinical trial assays that don’t align with the commercial CDx
   • Insufficient evidence for global regulatory expectations
   • Late discovery of EU IVDR or Asia-specific requirements
   • Assay changes that trigger bridging studies under tight timelines
   • Quality systems that don’t scale through the lifecycle

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CDx Strategy Built for Real-World Development

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Landrich Group partners with biopharma and diagnostics companies to design and execute CDx programs that are approvable, scalable, and globally aligned.

We support FDA Pre-Submission strategy, EU IVDR CDx planning, clinical study design aligned with therapeutic trials, assay lifecycle and bridging strategy, and quality and post-market readiness.

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Is Your CDx Program Ready?

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Many CDx risks remain hidden until late in development.

Our Companion Diagnostics Readiness Checklist helps teams assess drug–diagnostic alignment, clinical evidence sufficiency, global regulatory strategy, and quality and lifecycle readiness.

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Start with Strategy

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If you’re evaluating or advancing a CDx program, early strategic guidance can prevent costly delays.

Schedule a confidential CDx strategy consultation with regulatory and clinical experts experienced in global companion diagnostics programs.​​​