Drug + Device, Biologic + Device, or "Borderline" Products | Structured & Defensible
Combination products fail when teams treat them like "just a device" or "just a drug." We help you define the Primary Mode of Action (PMOA), align to the lead center, bridge QMS/cGMP obligations, and build an evidence plan that works across components without duplicative chaos.
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/human factors support, and submissions that don't tell a coherent cross-component safety story.
- PMOA decisions drive everything: lead center, pathway, and the structure of your evidence plan.
- Quality obligations overlap: device QSR/ISO 13485, drug cGMP, and combination-product-specific requirements must be bridged.
- Labeling must be unified: IFU, instructions, warnings, and claims must align across components and channels.
- Human factors is critical: dose delivery, user steps, and use-related risk must be demonstrated—not implied.
Combination Product Programs
Clear programs for complex products—strategy first, then controlled execution.
Combination Product Strategy Sprint (PMOA + Pathway)
Typical range: $4,500–$12,500
For teams needing to 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 lead center and jurisdiction are not 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+
For companies needing practical integration across device and drug/biologic quality obligations.
- Gap assessment: design controls, CAPA, complaints, change control, supplier controls
- Interface risk controls: component 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+
For complete submission support: 510(k), De Novo, IND, or NDA with coherent cross-component narrative.
- Submission drafting + assembly with device and drug/biologic sections aligned
- Human factors/usability integration across labeling, IFU, and use-related risk
- Response support for FDA questions across components
Who We Help
Drug-Device Products
Pre-filled syringes, autoinjectors, inhalers, transdermal systems where device and drug must be evaluated together.
Biologic-Device Products
Cell/gene therapy delivery systems, biologic administration devices where PMOA and quality systems need careful framing.
Borderline Classification
Products where "is it a device?" or "is it a drug?" is unclear and RFD strategy is necessary.
Human Factors Complexity
Products where use errors can lead to dose delivery failures, contamination, or adverse events.
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.
How We Run Combination Product Engagements
Strategy → controls → submission, with clear handoffs and no duplicative work.
PMOA & Lead Center
We lock PMOA, map components to regulatory categories, and align pathway and lead center strategy.
Quality Systems
We identify overlapping obligations, build interface controls, and create unified documentation that works for both sides.
Evidence & Labeling
We coordinate testing, human factors, and labeling so all components tell one coherent safety story.
Dossier & Defense
We assemble submissions with clear component boundaries and support cross-center questions without creating confusion.
Combination Product FAQs
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.