PHARMACEUTICAL REGULATORY SCIENCE MCQs with Answer | Topic-wise

Topic-wise MCQs with answers for PHARMACEUTICAL REGULATORY SCIENCE, covering drug discovery and development, global regulatory authorities, IND/NDA/ANDA pathways, CTD and dossiers, ethics and GCP in clinical trials, pharmacovigilance, export documentation, and key regulatory references such as the Orange Book, CFR and Purple Book.

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Stages of drug discovery process MCQs With Answer

PHARMACEUTICAL REGULATORY SCIENCE • 30 MCQs

PHARMACEUTICAL REGULATORY SCIENCE MCQs with Answer | Topic-wise

Stages of drug discovery process MCQs With Answer

Drug development phases and workflow MCQs With Answer

Pre-clinical study requirements and objectives MCQs With Answer

Non-clinical evaluation and safety testing MCQs With Answer

Clinical development phases I-IV overview MCQs With Answer

Difference between innovator and generic drugs MCQs With Answer

Concept and development of generic drug products MCQs With Answer

Overview of regulatory approval processes MCQs With Answer

Investigational New Drug (IND) application procedure MCQs With Answer

Timelines for IND submission and review MCQs With Answer

New Drug Application (NDA) approval process MCQs With Answer

Abbreviated New Drug Application (ANDA) process MCQs With Answer

Post-approval changes to NDA or ANDA MCQs With Answer

Overview of regulatory authorities in India (CDSCO) MCQs With Answer

Organization structure of US FDA and application types MCQs With Answer

European Medicines Agency (EMA) functions and approvals MCQs With Answer

Regulatory framework of Australia (TGA) MCQs With Answer

Regulatory system of Japan (PMDA) MCQs With Answer

Regulatory system of Canada (Health Canada) MCQs With Answer

Comparative study of regulatory authorities across countries MCQs With Answer

Procedure for export of pharmaceutical products from India MCQs With Answer

Documentation requirements for overseas registration MCQs With Answer

Drug Master File (DMF) – types and structure MCQs With Answer

Common Technical Document (CTD) format and modules MCQs With Answer

Electronic Common Technical Document (eCTD) MCQs With Answer

ASEAN Common Technical Document (ACTD) MCQs With Answer

Preparation and submission of regulatory dossiers MCQs With Answer

Clinical trial protocol development steps MCQs With Answer

Institutional Review Board (IRB) and Ethics Committee structure MCQs With Answer

Working procedures of Ethics Committees MCQs With Answer

Informed consent process and ethical considerations MCQs With Answer

Good Clinical Practice (GCP) obligations for investigators MCQs With Answer

GCP roles of sponsors and monitors MCQs With Answer

Clinical trial management and monitoring MCQs With Answer

Pharmacovigilance and safety monitoring in clinical trials MCQs With Answer

Basic regulatory terminology and definitions MCQs With Answer

Difference between guidance and guideline MCQs With Answer

Overview of laws, regulations and acts in drug approval MCQs With Answer

Orange Book – purpose and content MCQs With Answer

Federal Register – role in regulatory updates MCQs With Answer

Code of Federal Regulations (CFR) overview MCQs With Answer

Purple Book – biosimilars and biologics listing MCQs With Answer