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Regulatory Affairs and Support

Global Regulatory Submission Support for West Customers
West provides customers with industry-leading support for their global regulatory needs. We provide a single point of contact to assist you with your global registration strategies for all of our products and processes.

In North America, West has a large portfolio of Drug Master Files (DMFs), Master Access Files (MAFs), 510ks and Health Canadian Licenses with FDA and Health Canada to support customer drug registrations. To date, West has issued over 9,000 Letters of Authorization/Access (LOAs) for Regulatory Agency to access West DMF/MAF since 2008. The process for requesting LOAs is easy and can be performed online from anywhere in the world.

West can also provide you with support documentation to meet your global regulatory submission requirements, including: