Is your product a combination product?

FDA Combination products are defined in 21 CFR 3.2(e), as more products than ever fall into this category of 9 types of combination products. Take a look at the table below to see if your product is a combination product.

Looking to keep your combination product development moving along?

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.



Need help with your combination products?

Here at Kymanox, our experienced team of life science professionals is here to make your job easier. With our help, your combination products will be finished exactly when you need them to be. Our branded methodology process works by combining technical project management, fundamental engineering practices, quality expertise, and business acumen to get your project done more efficiently and to FDA guidelines.

It’s essential to adhere to all the necessary requirements when working with FDA combination products, and you don’t want to make any mistakes. Having a reliable team of experts on hand will help to ensure that everything goes according to plan throughout every step of the process. When you work with Kymanox, we’ll clarify everything you need to know about the FDA’s rules surrounding combination products and make sure you fully adhere to them. With our assistance, you’ll be able to devote yourself fully to the development of your product so it can reach the patients who need it without any obstacles.

Don’t try and take on this project alone. Turn to us to help reach your goals. We have experience with injectables, nasal, respiratory, and more. Call us today to get started with our services. Let’s get your products out there to create a better life for others.