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 Combination Products Info Sheet

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

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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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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)

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

Evan Edwards Combination Products SME Kymanox
Evan Edwards
HEAD OF HUMAN FACTORS REGULATORY
AND STRATEGY (HURAS)

EMAIL
evan.edwards@kymanox.com

MOBILE
+49 176 47990415

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

EMAIL
michael.denzer@kymanox.com

MOBILE
+1 908.963.2701

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

EMAIL
nick.schill@kymanox.com

MOBILE
+1 920.602.0932


Experts

Evan Edwards
Evan Edwards
HEAD OF HUMAN FACTORS REGULATORY
AND STRATEGY (HURAS)

EMAIL
evan.edwards@kymanox.com

MOBILE
+49 176 47990415


Michael Denzer
Michael Denzer
VICE PRESIDENT
TECHNICAL SOLUTIONS

EMAIL
michael.denzer@kymanox.com

MOBILE
+1 908.963.2701


Nick Schill
Nick Schill
SR. DIRECTOR
DEVELOPMENT

EMAIL
nick.schill@kymanox.com

MOBILE
+1 920.602.0932