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.

Nine types of combination products are given on the FDA web site—with descriptions and examples of each. Examples of some of the most common are:
  • 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

 

Swiss MPC has experience with the following systems:

  • Needle Safety devices
  • Auto Injectors
  • Glass staked needle syringes
  • Multi Dose inhalers
  • Vial Kits
  • Oral delivery syringes
  • Bottles (glass and plastic)
  • Caps and liners

Benefits of using Swiss MPC

  • Efficient Expertise - Our team has a wide range of exposure and experience accross the medical device landscape Competitive fees
  • Competitive fees
  • All in one team based solution
  • Excellent availability and fast project on-boarding
  • Senior Consultants as single point of contact
  • Staffing from 0.5 to 10 FTEs within 3 weeks
  • Fully remote working options available
  • Full quality control by Senior Consultants in Switzerland

Any questions? Receive an answer within 24 hours!