RQM+ delivers integrated and tailored regulatory, clinical, and market access support for pharmaceutical sponsors, biotech companies, and diagnostic developers advancing companion diagnostics (CDx) and precision medicine.
Whether your goal is full commercial launch or obtaining the right regulatory clearance to support therapeutic clinical trials — such as IVDR compliance for performance studies in the EU — our MedTech experts provide fully integrated solutions to streamline approvals and align with drug development timelines.
Why RQM+ for CDx?
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MedTech-Only CRO
100% focused on diagnostics and medical devices, with deep expertise in the co-development of companion diagnostics alongside therapeutic products.
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Therapeutic Alignment
Deep experience with CDER/CDRH, EMA, and IVDR co-development strategy.
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Integrated RA/QA/CA/CRO Services
Regulatory, clinical, and reimbursement support aligned with your drug partner’s timelines.
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Global Compliance Experts
U.S. FDA, EU IVDR, UKCA, and country-specific CDx frameworks (e.g., Japan PMDA).
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Flexible Engagement Models
Support for both commercial CDx approval and investigational-use-only strategies in the U.S., EU, and global markets.
Standards We Navigate
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FDA 21 CFR Parts 809, 812, 814 (PMA), and 820
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IVDR (EU 2017/746), Article 2(7), 56-77, and Annex XIII and XIV
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EMA GVP and Companion Diagnostic Guidelines
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ISO 13485 and ISO 20916
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ICH Q2(R2)/Q14 (analytical validation for biomarker assays)
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PMDA Companion Diagnostic Guidelines
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EUnetHTA HTA Core Model® for CDx value dossiers
Companion Diagnostic Life Cycle Support
Expand each to see key services.
Flexible Partnering Solutions
Full-Service Outsourcing
Fully managed CDx regulatory and clinical programs integrated with therapeutic timelines or stand-alone diagnostics programs.
End-to-end project ownership, from strategy to execution. Our managed outsourcing solutions enable easy collaboration, streamlined operations, and expert oversight so you can focus on what you do best.
Professional Consulting
Strategic guidance on co-development models, clinical trial use-only documentation, regulatory submissions, and performance data.
Industry-leading MedTech consultants with the strategic insight and regulatory expertise to solve your toughest challenges. Our global team stays ahead of evolving regulations to keep your innovations moving forward.
Professional Staffing
Embedded CDx experts to support development, agency interactions, and global compliance efforts.
Need an expert or a full team? We provide highly qualified MedTech professionals who integrate quickly and easily into your organization — the right people, right when you need them.