International Journal Of Drug Regulatory Affairs
  • Year: 2024
  • Volume: 12
  • Issue: 1

The regulatory affairs automation tools used in the pharmaceutical industry: An overview

  • Author:
  • Chandrasekaran Kumar1, T M Pramod Kumar2, V Balamuralidhara3
  • Total Page Count: 4
  • Page Number: 36 to 39

1PhD scholar, Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, Mysuru

2Professor Dept. of Pharmaceutics, JSS College of Pharmacy, Mysuru

3Associate Professor & Head Dept. of Pharmaceutics, JSS College of Pharmacy, Mysuru

Online published on 25 June, 2024.

Abstract

Automation is becoming increasingly prevalent in various industries, including healthcare and pharmaceuticals. The pharmaceutical business is influenced by a variety of worldwide trends, with one of the most significant being the use of automation technologies, which will have a transformative effect on the research and development of new pharmaceutical products as well as the speed and efficiency with which products reach patients in need. Regulatory automation is enabled by a variety of technology tools, such as Electronic Document Management Systems, Regulatory Information Management (RIM) Systems, Artificial Intelligence (AI) Analytics Tools, Natural Language Processing (NLP) Tools, and Submission Publishing Tools. Automation tools can be used to automate regulatory activities such as administrative work, dossier completion, data extraction, auditing, regulatory implementation as well as quality management. Automation tools establish process links and minimize complexity, resulting in a more efficient management system. Human-AI interaction creates new prospects in regulatory concerns. This article investigates the potential use of automation techniques in pharmaceutical regulatory concerns.

Keywords

Automation tools, Electronic Document Management Systems, Regulatory Information Management (RIM) Systems, Artificial Intelligence (AI) Analytics Tools, Natural Language Processing (NLP) Tools, And Submission Publishing Tools, ECTD submissions