03.28.23 -- De-Risk Combination Product Development

A drug-device combination product, such as a prefilled syringe or autoinjector, will have different drug and device requirements. This white paper examines the dynamic regulatory environment of drug-device combination products and provides concrete steps to take to navigate regulatory complexities and decrease time-to-market.

Regulatory requirements are challenging, and resources that understand bringing together both the drug and device development can be limited. When you work with West, you can de-risk your combination product development and regulatory strategies throughout drug-device development.

Collaborating with the right device contract manufacturers (DCMs) early on can have many benefits, including risk mitigation, innovative strategies, and a faster speed-to-market. Consider these guidelines when evaluating potential DCMs to choose one that will be the best fit for your company.

Building a control strategy comprises understanding the connectivity among materials of composition, components, constituent parts, final drug-device combination product, and critical process parameters. It requires risk-based consideration of routine controls focused on the aspects of the components that contribute to the essential functions.