Combination Products Service
The current definition of a combination product, according to the Code of Federal Regulations (CFR), is a product that involves a medical device and/or a drug and/or a biologic — combining any two of these product categories, and sometimes even all three.
Although many types of combination products have been available for years, recent FDA and EU guidance has clarified expectations from both a developmental and commercialization standpoint. This has led to increased industry challenges in meeting regulatory expectations.
- Drug-eluting stent
- Infusion pump
- Prefilled syringe
- Prefilled syringe in an autoinjector
- Drug-eluting balloon
- Drug-powder inhaler (DPI)
- Metered-dose inhaler (MDI)
About Swiss MPCs Combination Products Service
Swiss MPC has vast experience in DHF preparation for “off the shelf” and newly developed drug delivery systems, classified as “combination products”. Typical services we offer in this area are as follows:
· Market evaluation of “off the shelf” devices and primary packaging based on influential drug characteristics in order to select the best solution
· Assessment of combination product suitability for clinical trials
· Full commercial DHF completion encapsulating key drug product elements such as stability, leechable/extractables, etc.
· Verification activities including shipping verification studies, lab testing and test method development
· Contract manufacturer management and process validation supportContract manufacturer management and process validation support
· Human Factors Engineering and justifications based on accepted literature