Combo Products

Combination Products


Kymanox provides turnkey services to bring your combination product from concept to commercialization — and helps keep your product on the market. Our subject matter experts have the experience to be your ​end-to-end product and process development team.


Contact Us

Combination Products


Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Our subject matter experts have the experience to be your ​end-to-end product and process development team.


Contact Us


Our Device Experience

  • 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
  • Other Combo Products (ocular, intrathecal, oral, etc.)
  • Connected Devices / eHealth

Kymanox offers extensive go-to-market support and expertise to meet all your combination product needs.




Our Device Experience

  • 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
  • Other Combination Products (ocular, intrathecal, oral, etc.)
  • Connected Devices / eHealth

ComboProducts Flyer

Kymanox offers extensive go-to-market support and expertise to meet all your combination product needs.


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.


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Download: Combo Product Development Checklist


A comprehensive process is needed to make sure your combination product development project finishes on time and on budget.  This comprehensive checklist identifies the key phases and work packages to help you stay on track.


Bookmark(0)



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.


Bookmark(0)


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 combination products are still not well understood. Here are six things pharmaceutical companies need to understand to avoid potential problems down the road.


Bookmark(0)

Download: Combo Product Development Checklist


A comprehensive process is needed to make sure your combination product development project finishes on time and on budget.  This comprehensive checklist identifies the key phases and work packages to help you stay on track.



Bookmark(0)

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.


Bookmark(0)

Helpful Links

Here are some of our favorite FDA resources on this topic.


Combination Product Definition Combination Product Types


See how the FDA defines and classifies combo products.

Read More

Human Factors Considerations for Combination Products


A great introduction from Molly Folette Story, PhD.

Read More

CGMP Requirements for Combination Products


Current Good Manufacturing Practice Requirements for Combination Products FINAL GUIDANCE.

Read More

Combo Products Guidance Documents


A comprehensive and well-maintained list of links to FDA resources.

Read More


Helpful Links

Here are some of our favorite FDA resources on this topic.


Combination Product Definition Combination Product Types


See how the FDA defines and classifies combination products.

Read More

Human Factors Considerations for Combination Products


A great introduction from Molly Folette Story, PhD.

Read More

CGMP Requirements for Combination Products


Current Good Manufacturing Practice Requirements for Combination Products FINAL GUIDANCE.

Read More

Combination Products Guidance Documents


A comprehensive and well-maintained list of links to FDA resources.

Read More


Experts

Jason Miller
Jason Miller
Head of Engineering

EMAIL
jason.miller@kymanox.com

MOBILE
+1 317.508.4172

Michael Denzer Kymanox Combination Products SME Kymanox
Michael Denzer
VICE PRESIDENT
TECHNICAL SOLUTIONS

EMAIL
michael.denzer@kymanox.com

MOBILE
+1 908.963.2701

Nick Schill Kymanox Combination Products SME Kymanox
Nick Schill, PhD
SR. DIRECTOR
DEVELOPMENT

EMAIL
nick.schill@kymanox.com

MOBILE
+1 920.602.0932


Experts

Jason Miller
Jason Miller
Head of Engineering

EMAIL
jason.miller@kymanox.com

MOBILE
+1 317.508.4172


Michael Denzer Kymanox Combination Products SME
Michael Denzer
VICE PRESIDENT
TECHNICAL SOLUTIONS

EMAIL
michael.denzer@kymanox.com

MOBILE
+1 908.963.2701


Nick Schill Kymanox Combination Products SME
Nick Schill
SR. DIRECTOR
DEVELOPMENT

EMAIL
nick.schill@kymanox.com

MOBILE
+1 920.602.0932