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Date: 26 November 2019

Top 20 RA Interview Questions Asked in MNCs in Hyderabad

  • 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