Blog

• What do you mean by Regulatory Affairs and what are the roles of RA profession?
• Importance of stability studies and extrapolation conditions?
• What do you mean by bracketing and matrixing stability studies?
• What are the examples of significant change during stability studies?
• Types of impurities and how limit for each impurity will be assigned?
• what do you mean by genotoxic impurities and what is the limit for it?
• what do you mean by 4-tier specification and importance of each of them?
• what are the factors affecting dissolution studies, there limits and acceptance criteria?
• Define the term validation and explain different types of validation?
• what do you mean by bio-equivalence studies and its acceptance criteria?
• How many types of DMFs and Patent filing exist in the US?
• How many types of drug approval procedures are there in EU filling, narrate DCP and MRP timetable?
• Explain GDUFA, RTR, orange book and drug approval procedure in the US?
• what do you mean by CTD and how many modules are present in CTD?
• what are different post-approval types in US and EU?
• what do you mean by CEP and how its different from ASMF?
• Explain the terms EDQM, EMA,TGA, IND,NDA, ANDA & MAH?
• what do you mean by data exclusivity and marketing exclusivity?
• what do you mean by Para-IV filing in the US?

For complete responses contact sadhanainfotech.com/9390229797