A comprehensive synopsis on cognizance of Regulatory Affairs in different sectors of Pharmacy

  • Sukanya Paricharak Shardabai Pawar Institute of Pharmaceutical Sciences and Research , Shardanagar, Baramati
  • Atul Baravkar
  • Apeksha Masal
  • Sushma Chougule
  • Pooja Deshmane
  • Sachin Kulkarni


A pharmaceutical drug regulatory Affairs is mainly involved in registration process parameters of different pharmaceutical products and new drug application. Regulatory affairs (RA) professionals play vital roles in a pharmaceutical field as, it is related to healthcare products. It provides strategic, operational direction and support for working within regulations to expedite the development of pharmaceutical, biological and medical devices. Also, it is principally concern with safety and efficacy, low risk/high benefit and quality assessment of healthcare drug products throughout the world. Regulatory system of each and every country has different regulatory agencies which govern certification and good manufacturing practices. Regulatory Affairs also has a very specific importance within the formulation and marketing of drug product in pharmaceutical industries. Current abstract reports for the first time and emphasizes on studies concerning awareness and knowledge testing in regulatory affair field by the various pharma professionals. This is completely certified online survey of quiz questionnaire based on important concepts in RA and circulated via google form to different social medias to more than 1000 pharma professionals (Academics, Students, Industrials area). The systematic analysis of received responses reveals awareness and knowledge of the participants about RA in selected pharma professionals. It shows that, participants form industrial area having more knowledge than academics and students. This survey comes out with conclusion that, there is more need to raise RA information sources by the inclusion of this subject in syllabus for academics via various courses to fulfill more RA professional demands in future.

Keywords: Survey, Cognizance of regulatory affairs, Regulatory Affairs professionals, Regulatory agencies, safety and efficacy


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How to Cite
Paricharak, S., A. Baravkar, A. Masal, S. Chougule, P. Deshmane, and S. Kulkarni. “A Comprehensive Synopsis on Cognizance of Regulatory Affairs in Different Sectors of Pharmacy”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 4, Dec. 2021, pp. 20-32, doi:10.22270/ijdra.v9i4.495.