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
Submission Build & Response Support
Typical range: $20,000–$95,000+
For full submission authoring/assembly support across the relevant pathway (510(k), De Novo, IND/NDA/BLA elements as applicable).
- Cross-component narrative: risks, controls, performance, labeling consistency
- Human factors/usability strategy + documentation alignment
- Deficiency response support with tight document control
Who We Help
Drug-Device Delivery Systems
Autoinjectors, applicators, inhalation systems, topical delivery devices, and dosing accessories needing unified risk and labeling.
Device + Active Ingredient Products
Products where claims, mechanism, and intended use create category risk—and PMOA must be framed carefully.
Biologic/CGT + Device Interfaces
Systems that depend on device performance to deliver/activate a biologic therapy and require interface-focused controls.
OEM / Private Label Structures
Teams needing clarity on who is the legal manufacturer and how quality and regulatory responsibilities are allocated.
Usability-Driven Risk Products
Products with complex user steps where use-related risk and dose delivery must be demonstrated and documented.
Stalled / Conflicted Pathways
Programs stuck between centers or requirements—needing a clean strategy reset and controlled execution.
How We Run Combination Product Engagements
We reduce complexity by locking decisions early and keeping documentation consistent across components.
PMOA + Components
We define component roles, PMOA rationale, lead center strategy, and the submission architecture that follows.
Quality & Risk Bridging
We bridge QMS/cGMP expectations, align risk files, and define interface controls that reviewers can follow.
Testing + Usability
We map required testing (bench, HF, biocomp/sterility as needed) to claims, labeling, and risk mitigations.
Build + Defend
We assemble the dossier and manage responses with disciplined document control to avoid new inconsistencies.
Combination Product FAQs
How do you determine PMOA?
We evaluate the primary therapeutic action: is the main intended effect achieved through drug/biologic action or device function? PMOA drives lead center and submission structure, so we document the rationale clearly and defensibly.
Do we need an RFD?
Not always. If the lead center is clear, we may recommend a meeting strategy instead. When jurisdiction is ambiguous or stakes are high, an RFD strategy can help lock alignment and reduce costly rework.
What’s the most common combination product mistake?
Treating quality and labeling as “component problems.” FDA evaluates the integrated system—especially interface risks, user steps, and labeling consistency across the full product experience.
Are these pricing ranges fixed?
No—these are typical working bands. After a short triage call we can provide a fixed or milestone quote based on component complexity, quality system maturity, human factors scope, and your target pathway/timeline.
Talk Through Your Combination Product
Share your product components (drug/device/biologic), intended use, and where you are with quality systems and testing. We’ll outline a sequenced plan (PMOA → controls → evidence → submission) with clear deliverables and a quote aligned to your timelines.
Based in Charleston, SC • Supporting combination product teams worldwide
Prefer direct email? info@verusfda.com