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World Journal of Pharmacy & Pharmaceutical Research

WJPPR

World Journal of Pharmacy & Pharmaceutical Research

Review-Article

2026
VOLUME 03, SEPTEMBER ISSUE 09

A REVIEW OF “REGULATORY SUBMISSION FOR PHARMACEUTICAL DEVELOPMENT”

Author

Bala Mubassira*, Dr. Nidhi Chauhan, Patel Aksha Salim, Chauhan Keshiha, Sagar Dixit Kumar Kaushikbhai

Author & Research Contributor

Published in 2026 | VOLUME 03, SEPTEMBER ISSUE 09
DOI : https://doi.org/10.5281/zenodo.22261903

Abstract

Regulatory submission is an important process in the pharmaceutical assiduity that ensures drugs are safe, effective, and high in quality before they’re retailed. This review explains the part of nonsupervisory affairs in medicine development, clinical trials, manufacturing, quality assurance, and post-marketing conditioning. It describes different stages of clinical trials and medicine blessing processes followed in India and other countries. operations similar as IND, NDA, ANDA, and CTD are important for carrying blessing from nonsupervisory authorities. The review also highlights the significance of proper attestation, stability studies, process confirmation, and compliance with nonsupervisory guidelines. Organizations similar as USFDA, CDSCO, EMA, and ICH help maintain transnational nonsupervisory norms. Effective nonsupervisory submission systems ameliorate patient safety, product quality, and global pharmaceutical compliance throughout the product lifecycle.I

Keywords

IND, NDA, ANDA, CTD and MAA etc.