Solving Cold Chain Issues for
Drug‑Device Combination Products

How Modality Solutions Can Help

Modality Solutions’ transport validation studies and regulatory expertise help you meet rigorous FDA requirements for combination products and other innovative biomed devices. Our subject matter experts deliver everything you need to clear the hurdles and achieve a successful filing for your combination product or stand-alone medical technology.

• Regulatory expertise with BLAs and NDAs. Combination products present issues that cross the regulatory and scientific boundaries of both centers. Modality Solutions works extensively with both, understands how they operate, and knows what they require.
• Bridging strategies supported with transport simulation. When combining a device and a therapy, you need a scientifically sound and robust bridging strategy. Modality Solutions provides it — taking a risk-based approach that regulators will accept. We identify transportation risks and test them along the edges of the operating space in our one-of-a-kind transport simulation lab.
• Engineering-based comparative analysis. We review existing studies and assessments, then identify whether the risk profile of the drug or biologic constituents could affect the risk profile of the combination product. This comparative analysis pinpoints any differences between the original drug and device and the proposed combination product that could impact the cold chain.