1.What is CTD? Types of Modules in CTD format?
2.What is regulatory affairs?
3.Name some regulatory bodies?
4.What is ICH?
5.Name the all Quality guidelines in ICH?
6.What is DMF?
7.What is differences between ASMF and CEP?
8.Difference between the 505 (J) and 505 b(1) b(2) applications
9.What are the types of patent related para filings?
10.What are subsections in module-3?
11.What is the difference between Decentralized and Centralized procedures?
12.What is 505(e) application?
13.What are stability climatic zones?
14.Types of drug applications in US, Canada and Europe?
15.Significance of Orange Book?
16.Difference between RLD and RS?
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