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Home
About Us
Courses Offered
ENTRY LEVEL RA
MIDDLE LEVEL RA
PROFESSIONAL LEVEL RA
EXPERT LEVEL RA
CRASH COURSE
PHARMACOVIGILANCE (PV)
Aggregate Reporting
Clinical Research
Pharmaceutical Drug Development
Drug Substances (API)
Drug Approval procedure in US and EU
PHARMA VALIDATION
Quality Assurance
Student Placements
Our Services
Careers
Blog
Contact Us
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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
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