Are you facing these challenges?

  • Operator standing by assembly machine
    Challenge - Complex development processes and stringent regulatory requirements

    Challenge - Complex development processes and stringent regulatory requirements

    Both drug and product development are challenging in their own right. Add the complexity of developing a combination product and the stringent and evolving regulatory landscape, it is no wonder drug developers often make errors in their development path.

    Make data-driven decisions earlier in development

    With West, you can confidently plan each and every phase. West offers support services from concept and development, through to analytical testing, assembly, and regulatory filing, to help streamline the commercialization of drug delivery systems while mitigating risk.

    With West’s extensive knowledge of material science and experience in helping customers bring combination products to market, the burden to plan for every eventuality—even those you can’t predict—is reduced.

    Custom roadmaps mean that you have a clear line of sight to avoid pitfalls that might otherwise have been revealed too late. With this confidence in execution and by not having to constantly re-evaluate work, you can reduce development risk and accelerate time to market.

  • Axial Torison
    Challenge - Selecting the Ideal Presentation

    Challenge - 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. Against this backdrop, evolving regulations require you to prove your drug, containment and delivery system are reliable and safe.

    Design with the patient in mind

    When working with West, you will have the benefit of West’s extensive expertise to help you in selecting the right product for delivering an improved patient experience and in gathering the information you need to meet regulatory requirements.

    Having the ability to understand each unique combination product application and build the data to support product development is critical. With proper documentation of the containment and the delivery system, you can select the ideal presentation from the beginning. You’ll be able to navigate regulatory guidelines for combination devices, plus take advantage of user-centered design and testing to deliver a truly patient-centric product.

    When you do this, you mitigate the safety and usability risks that usually come with a new drug-delivery system, including meeting the increasing expectations of regulatory agencies.

  • Fill-Finish Support Services
    Challenge - Supply chain complexity

    Challenge - Supply chain complexity

    Developing combination products requires industry know-how from concept through commercialization. To fill in the gaps, you may rely on multiple suppliers, which could leave you with an overabundance of vendors to track and manage as you commercialize your drug, along with several service and quality agreements that you must constantly monitor.

    Because the dynamics and nature of the relationship are different, you need on-going collaboration and transparency. This calls for a partner who understand the unique challenges of building the components and the constituent parts of a drug-device delivery system.

    Simplify the supply chain without limiting options

    West’s vertical integration means that you can build visibility and accountability across the entire development, industrialization, and commercial phases.

    And with West’s breadth of components and presentations, you can access materials that have already been found to be suitable for combination devices, reducing the risk of complex life-cycle management and de-risking incompatibilities.

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