Combination Product Services

We understand the device, what's inside, and how they interact. Our subject matter experts have the experience to be your end-to-end product and process development team.

Development & Operations

  • • Product & Process Development
  • • CMC Services & Analytical Sciences
  • • Process Engineering
  • • MS&T and Supply Chain
  • • Human Factors Regulatory & Strategy (HURAS)
  • • Packaging Technology & Engineering
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    Quality, Regulatory, & Compliance

  • • Quality Assurance, Compliance & Auditing
  • • Quality Engineering
  • • Quality Control
  • • Regulatory Affairs
  • • Clinical & Medical Affairs
  • • CGxP Microbiology & Environmental Monitoring
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    Commissioning, Qualification, & Validation

  • • Validation Master Planning
  • • Facilities & Utilities CQV
  • • Lab & Plant Equipment CQV
  • • Computer System Validation (CSV)
  • • Process Validation
  • • Cleaning Validation
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    Strategy, Planning, & Execution

  • • Program & Project Management
  • • Technology Transfer
  • • Innovation Solutions
  • • Enterprise Resource Planning & Solutions
  • • Due Diligence
  • • Staffing Solutions
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    Combination Products & Services Where We Excel

    Injectables 

    • Prefilled Syringes (PFS)
    • Mechanical and Electromechanical Autoinjectors
    • Wearable Injectors
    • Dual Chamber Systems
    • Reconstitution Systems

    Respiratory

    • Metered Dose Inhalers (MDI)
    • Dry Powder Inhalers
    • Nasal Sprays

    eHealth

    • Connected Devices
    • Wearable Biosensors
    • Apps

    Other Combo Products

    • Ocular
    • Intrathecal
    • Oral
    • And More!

    Kymanox Combination Product Resources

    6 Things Pharma Needs To Know About Combo Products

    Even though USA FDA 21 CFR Part 4 has been around for a while, the regulations on combo products are still not well understood. Here are six things pharmaceutical companies need to understand to avoid potential problems down the road. 

    The 9 Types Of Combination Products Defined By The FDA

    Is your product a combination product?  Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category. 

    Meet our Combination Product Experts

    Jason Miller
    HEAD OF ENGINEERING
    Jason Miller
    Michael Denzer

    Frequently Asked Combination Product Questions (FAQs)

    What is a combination product?
    A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Under 21 CFR 3.2 (e), a combination product is defined to include: 
    1. A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity [often referred to as a “single-entity” combination product];
    2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products [often referred to as a “co-packaged” combination product];
    3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose) [often referred to as a “cross-labeled” combination product]; or
    4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect [another type of “cross-labeled” combination product].
    For more information on the nine types of combination products see our infographic here.
    What are some examples of combination products?
    Examples of single-entity combination products (where the components are physically, chemically or otherwise combined) (21 CFR 3.2(e)(1)): 
    • Monoclonal antibody combined with a therapeutic drug 
    • Device coated or impregnated with a drug or biologic 
    • Drug-eluting stent, pacing lead with steroid-coated tip, catheter with antimicrobial coating, condom with spermicide, transdermal patch 
    • Prefilled drug delivery systems (syringes, insulin injector pen, metered dose inhaler) 
    Examples of co-packaged combination products (the components are packaged together) (21 CFR 3.2(e)(2)): 
    • Drug or vaccine vial packaged with a delivery device 
    • Surgical tray with surgical instruments, drapes, and anesthetic or antimicrobial swabs 
    • First-aid kits containing devices (bandages, gauze), and drugs (antibiotic ointments, pain relievers) 
    Example a of product that may be cross-labeled combination products (components are separately provided but specifically labeled for use together) (21 CFR 3.2(e)(3) or (e)(4)): 
    • Photosensitizing drug and activating laser/light source 
    For more information on the nine types of combination products see our infographic here.