Newsletter | March 28, 2023

03.28.23 -- De-Risk Combination Product Development

Dynamic Regulatory Environment For Combination Products

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.

Guide To Addressing Regulatory Requirements And Testing For Combination Products

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.

Guidelines For Selecting A Combination Products Partner

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.

Control Strategy: What, When, Where, And Why For Drug-Device Combination Products

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.

What Can You Do To Minimize Risk As You Transition To A Combination Product?

Both expectations and the competitive environment of the injectable product development landscape are changing in relation to three key factors: self administration, ease of use, and competition. What can you do to overcome all the uncertainty and risk?

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