Combination Products

Combination products pose unique regulatory challenges due to the fact that they consist of drugs, devices and/or biologics that are combined and sold as a single entity. Each component is often regulated by different departments or agencies within each country. Due to this complexity, some countries choose to regulate combination products by designating a lead office based upon which product is considered dominant and other countries may take a hybrid approach. Some regulatory agencies require multiple approvals before a product can be marketed.

RJR has the global experience necessary to help you determine how your product will be categorized and help you achieve the proper regulatory approvals to bring that product to market in the desired country:

  • Classification determination of your combination product
  • Identification of the proper regulatory authority to work with
  • Proper business strategy and product development planning
  • Identification and interpretation of the appropriate combination product regulations
  • GMP requirements for the appropriate drugs/devices/biologics
  • Pre-submission meetings with regulators
  • Clinical Trial Notification preparation and filing Institutional Review Board review and meetings
  • Regulatory document preparation and submission to the appropriate authorities

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