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The clock is ticking once patents are filed, and you need to cope with rising development costs, concerns about quality, and more stringent regulatory requirements—it all adds up to more pressure and more risk.
To navigate the uncertainty around combination products, pharmaceutical companies will often focus on drug development and speed to market with simple, known containment systems and delay focusing on drug – device combination products until later phases. But thinking about your long-term lifecycle management (LCM) strategy early on could offer many benefits, including helping to solidify your market position.
When you work with West, you can Simplify the Journey™ by considering combination product development and regulatory strategies throughout drug-device development.
This makes it easier to plan for every phase of your product’s life cycle, and you’ll find it easier to avoid surprises, shorten timelines, improve operational efficiencies, and increase the probability of regulatory success.