Advance Combination Product Development with Pharma Technology Expertise

A drug device combination product pairs a drug or biologic with a delivery or diagnostic device so that the two function as a single therapy. Prefilled syringes, autoinjectors, on-body and wearable systems, and drug-device diagnostic pairings all fall into this category. What makes them difficult is that they have to satisfy pharmaceutical requirements and device requirements at the same time, under regulations that were written separately.

Oversight is shared. Depending on your product, review can involve CDER, CBER, and CDRH, with one center taking the lead based on your primary mode of action. 21 CFR Part 4 sets out how drug GMP and device quality system requirements apply together. Coordination across centers is where many programs lose time, which is why we recommend settling classification questions early rather than discovering them during review.

Primary mode of action, or PMOA, is the single therapeutic action that contributes most to your product’s intended effect. It determines which center leads your review and which regulatory pathway you follow. Getting it wrong, or leaving it ambiguous, can mean classification disputes, duplicate filings, and months of avoidable delay. We help you determine and document your PMOA with the rationale regulators expect to see.

Because the failure points sit between the two disciplines. A drug team can build an excellent CMC package and still miss design control obligations. A device team can execute flawless verification and still be caught by extractables and leachables. Combining pharma tech knowledge with device engineering and human factors is what allows a program to see the interfaces, and the interfaces are where combination products succeed or stall.

Earlier than most teams plan for. Formative studies are most valuable while the design can still change in response to what you learn. When usability issues surface after design lock, the redesign ripples through verification, validation, manufacturing, and your submission timeline. Building human factors into development from the start is one of the cheapest forms of risk reduction available to a combination product program.

No, and maintaining two is usually counterproductive. Running parallel drug and device systems duplicates effort, creates contradictions between procedures, and gives inspectors more surface area to question. We help you build one integrated quality system that satisfies 21 CFR 210 and 211 alongside 21 CFR 820, with design controls, risk management, change control, supplier quality, and complaint handling working as a single set of processes.

Typically, the device-side elements may need to be integrated: design controls and the design history file, design risk management, and complaint handling and post-market processes that account for device performance. Supplier quality usually needs to expand to cover device component and assembly partners. We start with a gap analysis against both frameworks, then build a prioritized plan to close what matters before your next milestone.

Yes, and this is a common source of misalignment. Development plans, change control, and quality agreements often diverge between the drug sponsor and the device partner, and the gap only becomes visible under inspection. We work across both organizations to align processes, clarify ownership, and make sure your combined quality system holds up when someone from outside looks at it.

Yes. A focused gap analysis will tell you where you stand against drug and device requirements and what has to close before your next milestone. Many of the programs we take on are already in motion, sometimes with a submission date already committed. We prioritize by regulatory consequence and put senior resources on the critical path.

Prefilled syringes, autoinjectors, on-body and wearable injectors, and drug-device diagnostic pairings, across small molecules, biologics, and cell and gene therapies. Our teams include experts across modalities and device types, so we match the right expertise to your product rather than applying one template to every program.

By preventing the expensive failures rather than remediating them. Late-stage integration problems, redesigns, duplicate filings, and inspection findings all cost far more than the work that would have avoided them. An integrated approach across pharmaceutical development, device quality, and regulatory strategy means fewer surprises, faster decisions, and less rework.

We are built to move fast. In many cases, we can begin within days and get you on a call with a subject matter expert within hours of connecting with us.