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Pharmaceutical drug development and commercial manufacturing is complex and risky. Packaging and drug delivery add challenges. With West by your side, you can find solutions to industry challenges such as:
At West, quality is more than a promise or a regulatory requirement — it's the foundation of everything we do to ensure we meet and exceed our customers' expectations while working to improve patient health. We recently rolled out a new Quality Policy across our organization, which highlights West’s commitment to a culture of excellence, emphasizing safety, sustainability, and continuous improvement.
By embedding quality into every aspect of our operations, West has established trust while also staying ahead of evolving regulatory requirements and Good Manufacturing Practice (GMP) standards.
Begin with the End in Mind and the Four “Hows” of Regulatory Success
To achieve a “right first time” submission, it is essential to clearly define the end goals of the regulatory submission. One of the most important goals of a submission is to support the patient or end user by ensuring that the device is accessible in the given market. A good regulatory submission proves that the device is both safe and effective for its intended use. Another goal to meet business needs requires establishing a straightforward path to the intended market, with minimal questions, which in turn expedites product delivery to the end user. While this might seem obvious, these goals can sometimes be overlooked during the progression of a project.
In August 2022 the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most frequently asked questions about Annex 1 and how it affects sterile drug manufacturers, which will be published across a multi-part series.
At West, quality is more than a promise or a regulatory requirement — it's the foundation of everything we do to ensure we meet and exceed our customers' expectations while working to improve patient health. We recently rolled out a new Quality Policy across our organization, which highlights West’s commitment to a culture of excellence, emphasizing safety, sustainability, and continuous improvement.
By embedding quality into every aspect of our operations, West has established trust while also staying ahead of evolving regulatory requirements and Good Manufacturing Practice (GMP) standards.
Begin with the End in Mind and the Four “Hows” of Regulatory Success
To achieve a “right first time” submission, it is essential to clearly define the end goals of the regulatory submission. One of the most important goals of a submission is to support the patient or end user by ensuring that the device is accessible in the given market. A good regulatory submission proves that the device is both safe and effective for its intended use. Another goal to meet business needs requires establishing a straightforward path to the intended market, with minimal questions, which in turn expedites product delivery to the end user. While this might seem obvious, these goals can sometimes be overlooked during the progression of a project.
In August 2022 the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most frequently asked questions about Annex 1 and how it affects sterile drug manufacturers, which will be published across a multi-part series.
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