Ideation
In the concept phase of a combination product, aligning the drug, device, or biologic components with regulatory and quality strategy is essential to set a clear path for development.
Regulatory Strategy and Regulatory Assessment
At the ideation phase of the combination product lifecycle, innovators and entrepreneurs should begin shaping a regulatory strategy and conducting a preliminary regulatory assessment. Developing a well-informed and forward-thinking strategy, particularly one that accurately defines the product’s primary mode of action (PMOA), is essential for establishing a realistic go-to-market timeline and development budget. Early regulatory planning not only guides technical decisions but also helps de-risk the program in the eyes of potential investors, strengthening your position during fundraising efforts.
OCP Request for Designation
In some cases, it may be necessary to submit a Request for Designation (RFD) to FDA’s Office of Combination Products (OCP) to determine the appropriate regulatory pathway based on your product’s primary mode of action. Covita Health Partners can guide you through the development of a strong RFD strategy and prepare a well-supported submission to help ensure a clear, favorable, and efficient determination to minimize regulatory uncertainty and aligning your development plan with the appropriate FDA center from the outset.
Quality Management System Strategy
Combination product companies should also start planning their quality management system strategy. Every innovator and entrepreneur want their product to not only get to market as quickly as possible, but they want it to stay there. A compliant quality management system is necessary to ensure that happens. This becomes more complex when having to ensure compliance with multiple Quality Management System (QMS)/Current Good Manufacturing Practice (cGMP) regulations for the device and drug/biologic components of the product. The QMS and cGMP regulations provide a framework, and it’s important to apply this framework appropriately to your organization and your product(s) to ensure that compliance is not achieved at the expense of being burdensome. A quality management system strategy will tell you what you need and when.
You do not need a full quality system at the outset. It’s important to phase-in your quality system as development progresses so that resources are allocated appropriately during the project. QMS elements we would recommend at this stage to facilitate success at the next phase are Document Control, Employee Training, and Procedures for Purchase.