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 of a combination product is often related by different departments of agencies within each country.
Due to the complexity of combination products, some countries choose to regulate combination products by designating a lead office based upon which product is considered the primary mode of action. Other countries may take a hybrid approach. Some regulatory agencies require multiple approvals before product can be marketed.
At RJR we can help you determine how your product will be categorized and help you achieve the proper regulatory approvals to bring your product to market in the desired country.
Due to the complexity of combination products, some countries choose to regulate combination products by designating a lead office based upon which product is considered the primary mode of action. Other countries may take a hybrid approach. Some regulatory agencies require multiple approvals before product can be marketed.
At RJR we can help you determine how your product will be categorized and help you achieve the proper regulatory approvals to bring your product to market in the desired country.
We offer the following services in the area of COmbination Products
- 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 drug/devices/biologics
- Pre-submission meetings with regulators
- Regulatory document preparation and submission to the appropriate authorities
- Clinical trial notification preparation and filing Institutional Review Board applications