As drug development becomes more complex, so are the challenges you face. Regulatory requirements are challenging, and there can be limited resources that understand bringing together the drug and device development. You can de-risk your filing process by addressing regulatory and resource challenges upfront, allowing you to achieve more timely drug development and regulatory submission.
As the material scientists that help develop injectable packaging and devices using expertise in ISO standards, USP chapters, FDA guidances, MDR article 117 requirements, and other pertinent regulations, we can help you achieve timely drug development and regulatory submission. When you work with West, you can de-risk your combination product development and regulatory strategies throughout drug-device development.