as of 2019 - 05 - 07

22.E Excipient master files and other filings

22.E Excipient master files and other filings
In this chapter you will find answers to the following questions:

What is a Drug Master File?

What is a certificate of Suitability?

What are the differences in forwarding information about excipients to the regulatory authorities within the three regions USA, Europe and Japan?

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