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: