Combination Products
Drug + Device. Biologic + Device. Borderline Products, Structured and Defensible.
Combination products fail when teams treat them like “just a device” or “just a drug.” We help you define Primary Mode of Action (PMOA), align to the lead center, bridge QMS/cGMP obligations, and build an evidence and labeling plan that works across components—without duplicative chaos.
Jurisdiction clarity
PMOA and lead center aligned early to prevent rework.
Unified quality
Bridge QMS and cGMP with practical interface controls.
Human factors
Use-related risks proven—not assumed—across steps.
One story
Cross-component evidence + labeling that reads cleanly.
Why delays happen
Why combination products get stuck
Combination products are about interface risk: drug/device interactions, labeling consistency, manufacturing controls, and who “owns” what. The most common delays come from unclear PMOA/lead center strategy, mismatched quality systems, incomplete usability support, and submissions that don’t tell a coherent cross-component safety story.
PMOA decisions drive everything
- Lead center alignment (CDER/CDRH/CBER) and pathway structure
- How your evidence plan is organized across components
- What “success” looks like for reviewer expectations
Quality obligations overlap
- Device QSR/ISO 13485 + drug cGMP + combo-specific requirements
- Change control and supplier controls at the interface
- Document control and traceability across components
Labeling must be unified
- IFU, warnings, claims, and instructions aligned across channels
- One “voice” across drug/device elements
- Consistency with human factors and risk controls
Human factors is critical
- Dose delivery and user steps must be demonstrated
- Use-related risks tied to labeling and mitigations
- HF evidence packaged for reviewer readability
Programs
Combination product programs
Clear engagements for complex products—strategy first, then controlled execution.
Combination Product Strategy Sprint (PMOA + pathway)
Typical range: $4,500–$12,500
Lock PMOA, lead center, and the minimum viable evidence plan before building the wrong dossier.
- PMOA analysis + pathway recommendation (device-led vs drug-led vs biologic-led)
- Component mapping: what is regulated as what, and why
- Evidence roadmap: bench/biocomp/usability + drug/biologic elements where applicable
RFD / lead center alignment package
Typical range: $6,000–$18,000
For products where jurisdiction isn’t obvious and you need a structured position.
- RFD strategy + drafting support (when appropriate)
- Regulatory positioning narrative + risk framing
- Meeting prep support and post-feedback action plan
QMS / cGMP bridging & controls pack
Typical range: $8,500–$35,000+
Practical integration across device and drug/biologic quality obligations.
- Gap assessment: design controls, CAPA, complaints, change control, supplier controls
- Interface risk controls: compatibility, dose delivery, storage/handling, labeling control
- Core SOP set + templates to support audits and submissions
Combination product submission build
Typical range: $20,000–$95,000+
End-to-end submission support with a coherent cross-component narrative.
- Drafting + assembly with device and drug/biologic sections aligned
- Human factors integration across labeling, IFU, and use-related risk
- Response support for FDA questions across components
Fit
Who we help
Teams navigating cross-center interfaces, interface risk, and quality system bridging.
Drug-device products
Pre-filled syringes, autoinjectors, inhalers, transdermal systems where device and drug must be evaluated together.
Biologic-device products
Delivery systems where PMOA, comparability, and quality systems need careful framing.
Borderline classification
Products where “is it a device?” or “is it a drug?” is unclear and an RFD strategy is necessary.
Human factors complexity
Use errors can lead to dose failures, contamination, or adverse events—HF must be designed and demonstrated.
Multi-center coordination
Teams navigating CDER/CDRH/CBER interfaces and needing clear ownership and documentation strategies.
Quality system gaps
Organizations with device QMS but no drug cGMP experience (or vice versa) needing practical bridging.
Process
How we run combination product engagements
Strategy → controls → submission, with clear handoffs and no duplicative work.
PMOA & lead center
Lock PMOA, map components to regulatory categories, and align pathway and lead center strategy.
Quality systems
Identify overlapping obligations, build interface controls, and create unified documentation that works for both sides.
Evidence & labeling
Coordinate testing, human factors, and labeling so components tell one coherent safety story.
Dossier & defense
Assemble submissions with clear component boundaries and support cross-center questions without confusion.
FAQs
Combination product FAQs
Straight answers for PMOA, RFD decisions, and quality bridging.
What’s the biggest mistake teams make with combination products?
Treating them as “device + some drug stuff” or “drug + some device stuff” without a coherent PMOA position and unified quality/evidence plan. This leads to mismatched documentation, unclear jurisdiction, and preventable delays.
Do we need an RFD for every combination product?
Not always. Many combination products have clear PMOA and established lead centers. RFD is most valuable when jurisdiction is unclear or when you need formal FDA input on classification.
Can we use the same quality system for device and drug components?
With proper bridging, yes. The key is identifying where QSR/ISO 13485 and cGMP overlap, where they diverge, and how to document interface controls that satisfy both.
Are these pricing ranges fixed?
No—these are typical working bands. After a triage call we provide a fixed or milestone quote based on PMOA complexity, quality system maturity, component count, and submission pathway.