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Have the data you need to mitigate product quality risk
As new biologics are developed and storage conditions and packaging become more complex, it is increasingly crucial to understand the integrity of the packaging and the appropriate methods for evaluating and testing it.
Collaboration with customers, combined with a thorough understanding of current regulations, enables our analytical services team to create and execute robust study designs ensuring you have the data you need to provide to the regulatory agencies. These studies cover syringes, cartridges, vials and all related components, devices and combination products such as pre-filled syringes, auto-injectors and on-body delivery systems. West not only tests products but we also develop and manufacture components, devices and combination products as well as contract manufacture devices for the pharmaceutical industry. Our team of scientists, engineers, product developers, and regulatory experts empowers our laboratory services clients from the pharmaceutical industry in gaining regulatory approval for new products that deliver medications to patients safely and effectively.
While ISO and guidance documents suggest useful test methods to assess the performance of components and devices, the final collection of tests to be included in a regulatory filing must be based on Design Inputs and risk assessments. By partnering with West, you are able to put together a holistic risk-based testing program.
Analytical technologies used for container closure integrity testing include:
Collaboration with customers, combined with a thorough understanding of current regulations, enables our analytical services team to create and execute robust study designs ensuring you have the data you need to provide to the regulatory agencies. These studies cover syringes, cartridges, vials and all related components, devices and combination products such as pre-filled syringes, auto-injectors and on-body delivery systems. West not only tests products but we also develop and manufacture components, devices and combination products as well as contract manufacture devices for the pharmaceutical industry. Our team of scientists, engineers, product developers, and regulatory experts empowers our laboratory services clients from the pharmaceutical industry in gaining regulatory approval for new products that deliver medications to patients safely and effectively.
While ISO and guidance documents suggest useful test methods to assess the performance of components and devices, the final collection of tests to be included in a regulatory filing must be based on Design Inputs and risk assessments. By partnering with West, you are able to put together a holistic risk-based testing program.
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