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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:
In the complex world of pharmaceutical development, drug developers have a lot to think about. From formulation and testing to containment and delivery, every decision carries risk, cost, and long-term implications. Making these decisions can be overwhelming in and of itself — but when you consider that the timing of each choice can influence the overall drug timeline, the challenge intensifies. These complexities call for a forward-thinking approach — one that considers not just today’s choices, but the ripple effects they create across the entire drug product lifecycle.
That’s why it’s critical not just to make the right decisions for the moment, but the smart ones that enable a successful launch — and, more importantly, ensure the long-term success and sustainability of your drug product.
The RAPS Philadelphia Chapter, in collaboration with West Pharmaceutical Services, convened regulatory, quality, and industry professionals for a dynamic session focused on the implementation of the FDA’s Quality Management System Regulation (QMSR). Held at West’s Exton, PA facility, the evening provided a collaborative forum for industry professionals navigating the transition from the longstanding Quality System Regulation (QSR) to the newly aligned framework modeled on ISO 13485.
The global pharmaceutical landscape continues to undergo rapid transformation. As the drug pipeline and the need for complex modalities such as biologics, advanced therapies, and mRNA-based treatments grow, the demand for high-quality, contamination-free primary packaging has never been greater. Regulators worldwide are challenging current practices and tightening standards, and patients are increasingly aware of final drug product safety. For pharmaceutical manufacturers, this translates into dual pressures; mitigating risk throughout the drug’s lifecycle and meeting stricter quality expectations to ensure patient safety and confidence.
In the complex world of pharmaceutical development, drug developers have a lot to think about. From formulation and testing to containment and delivery, every decision carries risk, cost, and long-term implications. Making these decisions can be overwhelming in and of itself — but when you consider that the timing of each choice can influence the overall drug timeline, the challenge intensifies. These complexities call for a forward-thinking approach — one that considers not just today’s choices, but the ripple effects they create across the entire drug product lifecycle.
That’s why it’s critical not just to make the right decisions for the moment, but the smart ones that enable a successful launch — and, more importantly, ensure the long-term success and sustainability of your drug product.
The RAPS Philadelphia Chapter, in collaboration with West Pharmaceutical Services, convened regulatory, quality, and industry professionals for a dynamic session focused on the implementation of the FDA’s Quality Management System Regulation (QMSR). Held at West’s Exton, PA facility, the evening provided a collaborative forum for industry professionals navigating the transition from the longstanding Quality System Regulation (QSR) to the newly aligned framework modeled on ISO 13485.
The global pharmaceutical landscape continues to undergo rapid transformation. As the drug pipeline and the need for complex modalities such as biologics, advanced therapies, and mRNA-based treatments grow, the demand for high-quality, contamination-free primary packaging has never been greater. Regulators worldwide are challenging current practices and tightening standards, and patients are increasingly aware of final drug product safety. For pharmaceutical manufacturers, this translates into dual pressures; mitigating risk throughout the drug’s lifecycle and meeting stricter quality expectations to ensure patient safety and confidence.
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