• Is your company’s product made up of both drug and device constituent parts?

  • Is the product destined for the US and the European markets and it is uncertain which would be best for most rapid time to market or least cost?

  • Have the regulatory differences and timelines between the US and Europe been determined?

  • Have clearly defined regulatory, clinical study and quality system strategies that will expedite project completion been developed?

 

 
There are important differences in US and European requirements for drug-device combination products and drug delivery devices. These differences can sometimes represent significant difficulties in reaching project milestones when they are not understood early enough in the project management process. GEMAR has the knowledge and experience to assist in the development of effective regulatory, clinical study, and quality system strategies so that important project milestones can be met.
 
 
When the product is to be marketed in the US, GEMAR can help you to determine:
 
 
  • The “primary mode of action” of the combination product and therefore which FDA Center will have the lead in the review

  • what type of marketing application will be required and what kind of safety and effectiveness information is needed to support approval

  • what good manufacturing practice or quality system regulations apply to the combination product

  • how adverse events should be reported for combination products

  • what are the applicable user fees for combination products

 
 
When the product is to be marketed in Europe, GEMAR can help you to determine:
 
 
  • whether the product will be subject to drug or device regulations or both
  • the type of clinical data that will be needed to meet the requirements for placing the product on the market
  • if clinical studies are needed, the manner in which they can be conducted to support US submissions without having to unnecessarily repeat clinical studies in the US
  • post-market requirements to prevent costly problems once the product is on the market