*Corresponding Author: Dr. Shaik Asha Begum, Head, Department of Regulatory Affairs, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada, Andhra Pradesh, India. Email: Sk.asha86@gmail.com
Background: The safety, effectiveness, and quality of pharmaceutical products are guaranteed by Regulatory Affairs (RA). However, traditional regulatory systems have resource constraints, documentation burdens, and delays.
Aim: Examine how RA functions can be re-engineered using artificial intelligence (AI), with an emphasis on education, innovation, and pharmaceutical ecosystem empowerment.
Methods: Evaluation of AI-enabled tools for documentation, submissions, and pharmacovigilance, along with a qualitative and analytical study based on regulatory frameworks (FDA, EMA, CDSCO, ICH).
Key Findings: Automation of regulatory documentation, predictive analysis, accelerated submissions, and improved compliance monitoring are all possible with AI. The Educate–Innovate–Empower model enhances data-driven decision-making, workflow redesign, and skill development.
Conclusion: If AI is implemented with appropriate governance and competency training, it can greatly modernise international regulatory systems.
Keywords: Regulatory Affairs, Artificial Intelligence, Pharma Technology, Compliance, Digital Transformation.
How to cite this article: Begum SA, Sahithi C, Vainavi V, Sri AS, Yamini B, Deekshitha VND, Sruthi B, Bhaskar L, Rao MT, Kumar VV. Re-engineering regulatory affairs with AI: an investigative study on education, innovation, and empowerment in pharma. Int J Drug Deliv Technol. 2026;16(7s): 264-267; DOI: 10.25258/ijddt.16.7s.30
Source of support: Nil.
Conflict of interest: None