Combination products offer the cutting edge of innovation, combining the finest of drug, biologic, and device technologies to transform patient care. However, their complexity necessitates the careful integration of regulatory, clinical, and marketing strategies. RQM+ is the combination product consulting lifeline, with a unique ability to help users through the whole product life cycle.
The company’s solutions for combination products are designed to guarantee adherence to standards, enhance operational performance, and expedite patient access.
Combination products consulting benefits
- Regulatory Integration: Proficiency in managing the dual regulatory frameworks required for FDA and international submissions
- Comprehensive Support: Tailored support encompassing consulting, clinical investigations, laboratory provisions, and reimbursement processes
- Accelerated Market Access: Streamlined and effective procedures to facilitate the user's combination product reaching patients more swiftly
Integrated life cycle approach: Beyond compliance
Achieving regulatory clearance for combination products necessitates alignment across their development, testing, and post-market stages. RQM+ assists the user across the full life cycle, guaranteeing adherence to regulations at each phase while maximizing the pace of market entry:
- Development: Formulating strategic plans to fulfill the specific requirements for drug-device combinations
- Testing: Coordinated biocompatibility and chemical characterization assessments specifically adapted for combination products
- Market entry: Complete submission dossiers and effective communication with regulatory agencies
- Post-market: Continuous oversight of compliance and reporting activities consistent with MDR and FDA benchmarks
- Gold standard lab and material science: Industry-leading materials testing and chemical characterization recognized by the FDA
- Global reach: Achieving successful regulatory filings throughout the United States, Europe, and the United Kingdom
Flexible partnering solutions
Outsourcing
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Outsourcing options are available, which are both customizable and scalable, designed to cover complete projects, particular functions, or specific segments of a function. Users can leverage RQM+'s specialized knowledge and adaptability, enabling user teams to focus on their primary competencies, organizational objectives, and innovative initiatives.
Consulting
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Specialized, results-oriented knowledge is provided to address specific MedTech challenges. Consultants from RQM+ offer practical, implementable advice and direct execution to ensure prompt problem resolution.
Staff augmentation
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Users can bridge skill or capacity deficits by utilizing MedTech professionals from RQM+. The organization supplies on-demand experts, functional service assistance, rapid deployment for urgent schedules, and contract-to-hire arrangements that integrate smoothly with the user's team.
Life cycle support
Design concept
- Regulatory
- EU: Borderline determination, EMA consultation
- Global regulatory pathway strategy
- Documents: Regulatory strategy memo, PMOA justification, briefing documents
- Product classification (drug vs. device vs. biologic-led)
- Primary mode of action (PMOA) analysis
- Jurisdiction strategy (CDRH/CDER/CBER, EMA, NCAs)
- FDA Intercenter Consult Request (ICCR) planning
- Quality
- cGMP vs. QSR mapping
- Risk management plan (ISO 14971)
- Combination product development framework alignment
- Device constituent quality planning
- Documents: Risk management plan, combination product quality plan
- Clinical
- Early feasibility assessments
- Clinical development plan concept (drug + device integration)
- Human factors planning
- Documents: Draft CDP, early clinical plan outline
- Reimbursement
- Combination product market and value proposition assessment
- Reimbursement landscape across drug and device pathways
- Documents: Early reimbursement strategy memo, HTA readiness assessment
- Labs (Jordi Labs)
- Material selection and formulation consulting
- Extractables/leachables strategy setup
- Documents: Material justification report, E/L testing strategy
- Medical writing
- Documents: TPP draft, outline of clinical utility rationale
- Draft TPP (Target Product Profile) including drug/device attributes
- Early IFU/label concept drafts
Design and development
- Regulatory
- EMA drug-device consultation support
- Documents: Pre-sub/Q-Sub packets, EMA consultation dossiers
- Meeting requests and briefing packages (FDA/EMA)
- Combination product classification confirmation
- IND vs. IDE determination (US)
- Quality
- Design control documentation for device constituent
- Integration of cGMP/QSR/QMS hybrid system
- Supplier and component traceability
- Documents: DHF, DMR drafts, QMS alignment plan
- Clinical
- Protocol design with drug-device endpoints
- Safety reporting structure planning (both CDER and CDRH/CDER split)
- Documents: Draft protocol, safety reporting SOPs
- Reimbursement
- Companion diagnostic and delivery method considerations
- Evidence-to-value strategy for hybrid pathways
- Documents: Reimbursement roadmap, payer messaging alignment
- Labs (Jordi Labs)
- Container/closure system compatibility
- Extractables and leachables method development
- Documents: Testing protocol, method validation reports (support only)
- Medical writing
- Risk-benefit narrative development
- Protocol authorship
- Documents: Draft protocol, target labeling document
Verification and validation
- Regulatory
- Device constituent regulatory impact assessment
- Verification and validation planning support (not execution)
- Documents: Verification planning rationale, validation summary memo
- Quality
- Design validation documentation (support only)
- Test method documentation support
- Documents: TMV protocol support, validation documentation templates
- Clinical
- Site qualification planning
- Final protocol completion
- Documents: Final protocol, monitoring plan
- Reimbursement
- Coding implications of product configuration
- Documents: Coding rationale document
- Labs (Jordi Labs)
- Execution of E&L testing, biocompatibility
- ISO 10993 testing strategy
- Documents: Biocompatibility reports, E/L test reports
- Medical writing
- Risk-based justification summaries
- IFU drafts with validated content
- Documents: IFU, Instructions for administration/use, Safety summary
Clinical evidence generation
- Regulatory
- Risk-based monitoring strategy consultation
- Clinical trial submission support (IND, IDE, CTAs)
- Documents: Clinical protocol, IND/IDE/CTA documentation
- Quality
- GCP compliance guidance
- Clinical quality SOPs
- Documents: Clinical SOPs, monitoring logs
- Clinical
- Real-world evidence setup, if applicable
- Full trial execution (project management, monitoring, data management)
- Documents: CSR, study reports, safety summaries
- Reimbursement
- Economic endpoint strategy
- Clinical value justification
- Documents: Value dossier contributions
- Labs (Jordi Labs)
- Stability testing
- Product interaction evaluations
- Documents: Stability report, compatibility analysis
- Medical writing
- Clinical summaries for regulatory submission
- CSR development
- Documents: CSR, Summary of Clinical Safety, Summary of Clinical Efficacy
Manufacturing readiness
- Regulatory
- EMA/Notified Body consultation
- Drug-device combination compliance strategy (e.g., CFR 4)
- Documents: Manufacturing SOPs (support), bridging justifications
- Quality
- Final DMR/DHF review
- Process validation documentation (support only)
- Documents: Validation plan (documentation support), lot release SOPs
- Clinical
- Finalize IFU and training materials for HCPs
- Documents: Training plan, clinical performance checklist
- Reimbursement
- Payer-facing clinical utility justification
- Documents: Updated economic model or HTA pre-submission package
- Labs (Jordi Labs)
- Final E&L, stability, shelf-life support
- Documents: Final test reports
- Medical writing
- Manufacturing/administration documentation for submission
- Final IFU/label content
- Documents: Administration guide, packaging insert
Regulatory submissions
- Regulatory
- Responses to FDA/EMA/NB queries
- Submission compilation and formatting (eCTD, 510(k), PMA, BLA/IND)
- Drug-device combination modules (Module 3, Annex I per MDR)
- Documents: Full regulatory submission, RTA checklists, deficiency responses
- Quality
- Audit readiness support
- Documents: Audit response documents
- Clinical
- Clinical evaluation report (CER)
- Clinical summaries (EU and US)
- Documents: CER, SSCP
- Reimbursement
- Health economics inclusion in submission (optional)
- Documents: HTA-ready value dossier sections
- Labs (Jordi Labs)
- Inclusion of a full chemistry and toxicology package
- Documents: Chemical characterization summaries
- Medical writing
- Regulatory writing support for submission documents
- Compilation of technical documents
- Documents: Clinical Overview, 2.7.1–2.7.4 summaries
Market access and launch
- Regulatory
- Labeling translation review (EU)
- Global registrations
- Documents: Registration forms, packaging content
- Quality
- Product complaint system setup
- Post-market surveillance planning
- Documents: PMS plan, complaint handling SOPs
- Clinical
- Registry planning
- PMCF plan
- Documents: PMCF plan, RWD study framework
- Reimbursement
- Payer engagement
- Coding assignment (US: HCPCS, EU: NUB)
- Documents: Coding request letters, coverage justifications
- Labs (Jordi Labs)
- Real-time aging studies
- Ongoing batch testing
- Documents: Batch test reports
- Medical writing
- Payer communication tools
- PMCF study documents
- Documents: PMCF protocols, evidence summaries
Post-market activities
- Regulatory
- Periodic safety update reports (PSUR)
- Vigilance support
- Documents: PSUR, MDRs
- Quality
- Periodic audit support
- CAPA system setup and oversight
- Documents: CAPA reports, internal audit plans
- Clinical
- PMCF surveys and studies
- Documents: PMCF reports, clinical update summaries
- Reimbursement
- HTA reassessment submissions
- Documents: Updated value dossiers
- Labs (Jordi Labs)
- Long-term stability and impurity profiling
- Documents: Updated test reports
- Medical writing
- PMS-related narrative reports
- Safety summary reports
- Documents: PSUR narrative, PMS summary
Design changes, M&A, and market expansion
- Regulatory
- Global change notification support
- Change impact assessments
- Documents: Supplement submissions, change memos
- Quality
- QMS integration planning (post-M&A)
- Change control documentation
- Documents: Updated SOPs, integration plan
- Clinical
- Bridging studies and labeling extensions
- Documents: Bridging protocol, justification memo
- Reimbursement
- Pricing update strategy
- Documents: Payer re-engagement materials
- Labs (Jordi Labs)
- New formulation testing
- Comparative testing
- Documents: Side-by-side chemical assessments
- Medical writing
- Update IFU, CERs, and submission modules
- Documents: Revised CER, Summary of Product Characteristics
Emergency support
- Regulatory
- Emergency meeting request drafting and response strategy
- Regulatory remediation (warning letter, CE mark suspension)
- Documents: Remediation plans, briefing docs
- Quality
- QMS overhaul under tight timelines
- CAPA plans under regulatory scrutiny
- Documents: CAPA logs, QMS revision memos
- Clinical
- Emergency PMCF implementation
- Safety incident investigation
- Documents: Safety reports, rapid evidence summaries
- Reimbursement
- Payer renegotiation following adverse events
- Documents: Risk mitigation plan
- Labs (Jordi Labs)
- Confirmatory testing under urgent conditions
- Documents: Emergency test summary
- Medical writing
- Urgent regulatory communications
- Root cause analysis documents
- Documents: Safety notices, response narratives