De-Risk the Transition to Combination Products

There's a lot of uncertainty when developing a combination product. And you may face several challenges that can delay product development and launch. With accelerated timelines and growing competition, you don't have time to get stuck in re-do loops. When you work with West, you can Simplify the Journey ? by considering combination product development and regulatory strategies throughout drug-device development.

West can partner with you to get your product to market faster while mitigating risk

As a drug developer, you’re under pressure to accelerate timelines while remaining conscious of development costs, quality, and regulatory requirements.

Therapies are increasingly complex, and patient and payor expectations are growing, which drives demand for more intricate drug delivery systems and results in new regulations.

Challenges in Drug Development

Navigating Regulatory Requirements

Both drug and product development are challenging in their own right. Add the complexity of developing a combination product and constant changes to regulations, it is no wonder drug developers often make errors in their development path. Do you have the expertise to interpret the regulations and avoid compliance challenges?

Supply Chain Complexity

Developing a combination product requires industry know how from concept through commercialization. To fill in the gaps, you may rely on multiple suppliers, but managing this complex supply chain requires substantial resources and exposes you to risk.

Selecting the Ideal Presentation

As therapies become more complex and shift towards self-administration, you're pressed to bring more intricate devices to market that are also easy to use. Evolving regulations require you to prove your drug, containment and delivery system are reliable and safe.

Key Considerations for Combination Product Development

1

Regulatory Insight

As technology evolves to meet the needs of patients, device options are expanded to cover multiple delivery profiles and drug types.

2

Analytical Testing

Assisting customers in designing studies while navigating the challenging and evolving regulatory landscape for combinations products.

3

Contract Manufacturing

Supporting customers with solutions to mitigate risk, improve operational efficiencies, reduce operating costs and delivery value to our medtech and pharma partners.

4

Device Assembly & Packaging

For customers seeking value-added assembly, from multi-component, complex assemblies that are manually assembled to high-speed assembly systems.

5

Device Performance Testing

In many instances, injectable pharmaceuticals need to be administered by patients or their caregivers rather than by healthcare professionals. The process can be greatly simplified with the use of auto-injectors.

6

Fill-Finish Enablement

Today’s fill/finish equipment technologies present various options to meet today’s manufacturing requirements including the flexibility to launch with multiple delivery presentations from vials, Pre-filled syringes to combination devices.

Want to Learn More?
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Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
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