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?
<br/>Looking for an end-to-end solution for your next development project? 
Development Pathway Image For Derisk Landing Page
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
日本亚洲精品色播 黄冈市| 阿尔山市| 商城县| 花莲县| 繁峙县| 丰台区| 开原市| 上思县| 阿尔山市| 铜鼓县| 乐安县| 宁乡县| 南阳市| 河池市| 和静县| 独山县| 璧山县| 偃师市| 栾城县| 墨竹工卡县| 永寿县| 高陵县| 北海市| 永安市| 团风县| 博罗县| 北辰区| 绵竹市| 阿城市| 合江县| 永清县| 日照市| 金堂县| 怀集县| 天峻县| 治多县| 衡水市| 武强县| 岗巴县| 衡东县| 盐亭县| http://www.vkslwqlk.xyz http://twrhzncj.xyz http://www.gbvftgis.xyz