Combination Products
Drug & Device Strategy Alignment
Combination product development requires not only expertise in both drugs and devices, but also an understanding of how to assess the compatibility of the drug/biologic with the device and the interaction of the users with the product.
Our experts help you understand and manage the complexities of combination product development. Our CMC, device, non-clinical, and clinical teams work cross-functionally with you to develop an integrated approach to your product development strategy. We assess your product, its primary mode of action, indications for use, and your goals and timelines to help you develop both clinical stage and commercial strategies.
Our company integrates innovative approaches, world-class scientific principles, regulatory proficiency, and a committed team to deliver combination product regulatory design and development solutions that yield a positive impact on public health and the quality of life for patients.
Guiding You Every Step of the Way
- Determine the primary mode of action and regulatory pathway
- Determine required testing
- Assist in device selection if an off-the shelf solution is being sourced
- Assist in integrating a delivery device into an existing drug program
- Determine bridging requirements in the case of changes to a delivery device
- Device manufacturer relationship management