Combination Products
Combination products pose unique regulatory challenges since they consist of drugs, devices, and/or biologics that are combined and sold as a single entity or co-packaged together. Each component of a combination product may be regulated by different departments within each applicable healthcare authority.
Due to this complexity, some countries choose to regulate combination products by designating a lead office based on which product is considered the "primary mode of action". Other countries may take a hybrid approach. Some agencies require multiple approvals before a combination product can be marketed.
RJR can help you determine how your product will be categorized to achieve the proper regulatory approvals to bring your product to market in the desired countries.
Due to this complexity, some countries choose to regulate combination products by designating a lead office based on which product is considered the "primary mode of action". Other countries may take a hybrid approach. Some agencies require multiple approvals before a combination product can be marketed.
RJR can help you determine how your product will be categorized to achieve the proper regulatory approvals to bring your product to market in the desired countries.
We offer the following combination product regulatory services:
- Classification/Determination of the Primary Mode of Action (PMOA)
- Request for Designation (RFD) meetings with FDA
- Identification of the proper regulatory authorities in chosen markets
- Proper business strategy and product development planning
- Identification and interpretation of the appropriate combination product regulations
- GMP requirements for the appropriate constituent parts of the combination product
- Pre-submission meetings with regulators
- Regulatory document preparation and submission to the appropriate authorities
- Clinical trial notification preparation and filing Institutional Review Board applications