Build CDx Programs That Support Drug Approval
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.
Where CDx Programs Commonly Break Down
• 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
CDx Strategy Built for Real-World Development
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.
Is Your CDx Program Ready?
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.
Start with Strategy
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.
Preparing Your Global CDx Strategy
Clinical & Regulatory Roadmap for Global CDx Programs
Gain insights into critical clinical and regulatory considerations—click below to learn more
Why Global CDx Strategy Is Critical
Introduction
Addressing Global Co-Development Complexity Early
Discovery &
Feasibility Strategy
Managing Limited Samples, Assay
Bridging, and Global Evidence Needs
Clinical Development Strategy
Receive Our Extensive Global Readiness Checklist
Region-Specific Challenges and Expectations
.png)
Quality & Risk
Management Readiness
Commercial & Market Readiness Access
Next Steps
FAQS
• When should a biomarker be evaluated for CDx development?
• How do companies decide whether a diagnostic should be companion, complementary, or exploratory?
• What makes biomarker-positive populations difficult to study in CDx programs?
Clinical & Regulatory Alignment
• Why does CDx strategy need to align with therapeutic development?
• What evidence is expected for CDx approval in the US?
• How early should CDx clinical evidence strategy be defined?
• Why is sample governance important in CDx clinical trials?
• What happens if the CDx clinical trial assay changes during development?
• Why is addy bridging important?
• How are multiple assays for one biomarker handled?
• Why is early regulatory engagement recommended for CDx programs?
• How do CDx regulatory pathways differ between the US, EU, China, and Japan?
• Why are design controls important for companion diagnostics?
• Why must CDx programs plan globally?
• Why does post-market planning matter so much?
• Why do CDx products struggle after approval?
• Why must CDx programs consider reimbursement early?
Global Strategy
• How can companies assess whether their CDx program is truly ready for global development?