Companion Diagnostics

Companion Diagnostics (CDx) Solutions for Pharma, Biotech, & Diagnostic Developers

Companion Diagnostics (CDx) Solutions for Pharma, Biotech, & Diagnostic Developers

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.

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Why RQM+ for CDx?

  • MedTech-Only CRO

    100% focused on diagnostics and medical devices, with deep expertise in the co-development of companion diagnostics alongside therapeutic products.

  • Therapeutic Alignment

    Deep experience with CDER/CDRH, EMA, and IVDR co-development strategy.

  • Integrated RA/QA/CA/CRO Services

    Regulatory, clinical, and reimbursement support aligned with your drug partner’s timelines.

  • Global Compliance Experts

    U.S. FDA, EU IVDR, UKCA, and country-specific CDx frameworks (e.g., Japan PMDA).

  • 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

  • FDA 21 CFR Parts 809, 812, 814 (PMA), and 820

  • IVDR (EU 2017/746), Article 2(7), 56-77, and Annex XIII and XIV

  • EMA GVP and Companion Diagnostic Guidelines

  • ISO 13485 and ISO 20916

  • ICH Q2(R2)/Q14 (analytical validation for biomarker assays)

  • PMDA Companion Diagnostic Guidelines

  • EUnetHTA HTA Core Model® for CDx value dossiers

Companion Diagnostic Life Cycle Support

Expand each to see key services.

  • Regulatory 
    • Biomarker-CDx alignment strategy for drug labeling 
    • IUO/RUO vs. CDx classification guidance (US and EU) 
    • EU IVD requirements for assays used in trials (require IVD certification even if investigational) 
    • Companion diagnostic regulatory development roadmap 
  • Quality 
    • QMS gap analysis for diagnostic partners or labs 
    • GCLP-compliant planning for assay use in clinical trials 
    • Early quality system setup for future CDx or IUO alignment 
  • Clinical 
    • Biomarker and trial design strategy 
    • Trial schema alignment to biomarker stratification (adaptive, enrichment models) 
    • Clinical strategy to support therapeutic trial with investigational assay 
    • EU: clinical evidence planning for IVDR if CDx transition is likely 
  • Reimbursement 
    • Early payer landscape assessment 
    • Exploratory HEOR and diagnostic value modeling tied to drug indication 
  • Medical Writing 
    • Drafting biomarker rationale for protocols and investigator brochures 
    • Positioning of assay as investigational in trial documents 
    • EU-specific IFU (Instructions for Use) documentation for investigational IVDs 
  • Regulatory 
    • IND or IDE regulatory strategy (if assay affects trial endpoints or subject stratification) 
    • Companion diagnostic co-development alignment with therapeutic timeline 
    • Pre-submission planning with FDA or Notified Body 
  • Quality 
    • Vendor qualification and audits (central labs, CROs, assay developers) 
    • Quality documentation support for LDT or IUO under clinical trial use 
    • CLIA, ISO 13485, and IVDR lab compliance review 
  • Clinical 
    • Protocol development including assay integration 
    • Site and lab qualification 
    • Biomarker stratification training and data capture plans 
  • Reimbursement 
    • Risk-based evidence plan for future payer support 
    • Clinical utility framework for companion diagnostics 
  • Medical Writing 
    • Study protocol input (biomarker sections) 
    • Informed consent language for assay use 
    • Analytical validation plans and summaries 
  • Regulatory 
    • Support for IUO documentation for IND or IDE 
    • Evidence generation plan aligned to FDA and IVDR expectations 
    • EU: confirmation of analytical performance as per IVDR Annex I 
  • Quality 
    • Design control documentation 
    • Verification protocol support (analytical precision, accuracy, specificity) 
    • Documentation to support regulatory submission or trial audit readiness 
  • Clinical 
    • Coordination of validation data with clinical endpoints 
    • Analysis of biomarker-stratified outcomes 
    • EU: Clinical performance data planning for IVD certification 
  • Reimbursement 
    • Incorporating real-world elements into validation design (where applicable) 
    • Evidence mapping to potential HTA requirements 
  • Medical Writing 
    • Drafting validation reports (analytical and clinical) 
    • Cross-linking assay performance to therapeutic claims 
    • Preparing content for regulatory submission or scientific publication 
  • Regulatory 
    • Regulatory support for clinical protocols and endpoints tied to biomarker use 
    • EU: Ensuring IVD certificate or performance study application is in place 
    • FDA meeting prep (Type C, Pre-Sub) for assay data 
  • Quality 
    • Oversight of assay use and data integrity during trials 
    • Data traceability support for biomarker performance 
  • Clinical 
    • Trial execution support with embedded assay use 
    • Risk-based monitoring of assay-related endpoints 
    • Multi-arm and enrichment trial design consulting 
  • Reimbursement 
    • Capture of clinical utility evidence 
    • Drafting of payer-facing clinical summaries post-trial 
  • Medical Writing 
    • Interim and final CSR sections related to biomarker and assay 
    • Clinical evaluation reports for EU if conversion to CDx occurs 
    • Regulatory briefing documentation 
  • Regulatory 
    • Companion diagnostic module preparation for NDA/BLA/MAA 
    • Standalone CDx PMA/510(k) submission support 
    • EU: Performance evaluation reports, GSPR, Technical Documentation per IVDR 
  • Quality 
    • Final design history file and DHF compilation 
    • Risk management file preparation 
    • Traceability matrix linking assay to therapeutic use 
  • Clinical 
    • Final trial evidence summaries 
    • Preparation for clinical site inspection or audits 
  • Reimbursement 
    • Dossier development for EU payers and US CMS engagement 
    • Mapping evidence to coding/reimbursement pathways 
  • Medical Writing 
    • Submission-ready labeling, IFU, and summary of safety and performance 
    • PMA/510(k) narrative components 
    • EMA or NB response packages 
  • Regulatory 
    • Post-approval change support 
    • Labeling alignment with drug 
    • EU: Notified Body communication and updates 
  • Quality 
    • Supplier and lab network quality agreements 
    • CAPA, complaint handling, and postmarket change management 
  • Clinical 
    • Postmarket performance studies (if required) 
    • Evidence generation for new indications 
  • Reimbursement 
    • Payer engagement and evidence updates 
    • Coding pathway activation (PLA, Z-code) 
  • Medical Writing 
    • Clinical utility publications 
    • Label updates 
    • HTA submission writing 
  • Regulatory 
    • Vigilance reporting (MDR) 
    • Labeling change support 
    • PMCF/PMPF plan development 
  • Quality 
    • Ongoing QMS support 
    • Supplier audits 
    • Complaint trending analysis 
  • Clinical 
    • PMCF study oversight 
    • Registry participation and data integration 
  • Reimbursement 
    • Evidence refresh to maintain coverage 
    • Price renegotiation strategy 
  • Medical Writing 
    • PMCF reports 
    • Labeling changes 
    • Scientific publications for long-term data 
  • Regulatory 
    • Response strategy for FDA/EMA/Notified Body 
    • CAPA documentation 
    • Reclassification strategy 
  • Quality 
    • Rapid QMS remediation 
    • SOP gap analysis and rewrite 
    • Field action documentation 
  • Clinical 
    • Root cause analysis of trial deviation or failure 
    • Emergency study redesign 
  • Reimbursement 
    • Damage control with payers 
    • Evidence remediation planning 
  • Medical Writing 
    • Crisis response documentation 
    • Justification memos 
    • Incident reports

Flexible Partnering Solutions

Full-Service Outsourcing

Outsourcing

Customizable and scalable outsourcing scoped for entire projects, specific functions, or defined parts of a function. Leverage RQM+ expertise and flexibility while your teams stay focused on core competencies, corporate goals, and innovation. Partner with us.

Professional Consulting

Consulting

Targeted, outcome-focused expertise to solve defined MedTech challenges. RQM+
consultants step in with practical, actionable guidance and hands-on execution to drive timely resolution. Partner with us.

Professional Staffing

Staff Augmentation

Fill skill or capacity gaps with MedTech talent from RQM+. We provide on-demand
professionals, functional service support, fast deployment for tight timelines, and
contract-to-hire options that integrate seamlessly with your team. Match with a contractor.

Partner with the Experts in Companion Diagnostics

Whether you’re pursuing FDA PMA approval, IVDR compliance for in-house tests or for investigational use in performance studies, or payer-ready HTA strategy, RQM+ brings unmatched regulatory and clinical strength to your CDx journey.

Contact us to accelerate your companion diagnostic to market or clinic.

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