Pharmaceutical Regulatory Affairs: Regulatory Functions, CTD Requirements, and ECTD Submission

Swetha, Vadapally; Rajitha, Nagilla; Sravanthi, Chada

doi:https://doi.org/10.55041/ijcope.v2i8.121

Volume 02, Issue 8

Published on: August 2026

PHARMACEUTICAL REGULATORY AFFAIRS: REGULATORY FUNCTIONS, CTD REQUIREMENTS, AND ECTD SUBMISSION

Vadapally Swetha Nagilla Rajitha Chada Sravanthi

Dr. Kotra Chandrasekhar Rangaiah

Siddhartha Institute of Pharmacy, Ghatkesar,Affliated to JNTUH,Hyderabad,T.S. India.

DOI:https://doi.org/10.55041/ijcope.v2i8.121

Article Status

Plagiarism Passed Peer Reviewed Open Access

Available Documents

Download PDF Review Report

Abstract

Drug Regulatory affairs is a vital unit in a pharmaceutical Industry. As the Pharmaceutical sector is rising very rapidly, there is a need of regulatory affairs professionals to provide the current needs of industries for the global competition. Drug Regulatory affairs professionals are the crucial link between pharmaceutical industries and worldwide regulatory agencies. Pharmaceutical product approval process should be a critical step in ensuring access to safe and effective drugs. Central Drugs Standard Control Organization (CDSCO), India has decided to adopt CTD format for technical requirements for registration of pharmaceutical products for human use. Implementation of CTD is expected to significantly reduce time and resources needed by industry to compile applications for global registration. This present article discusses the evolution of Drug Regulatory Affairs, its role in Pharmaceutical industry and its involvement for the implementation of CTD guidelines to regulate the marketing of the drugs and improve the growth of the industry.

How to Cite this Paper

Swetha, V., Rajitha, N. & Sravanthi, C. (2026). Pharmaceutical Regulatory Affairs: Regulatory Functions, CTD Requirements, and ECTD Submission. International Journal of Creative and Open Research in Engineering and Management, <i>02</i>(8), 1-9. https://doi.org/10.55041/ijcope.v2i8.121

Swetha, Vadapally, et al.. "Pharmaceutical Regulatory Affairs: Regulatory Functions, CTD Requirements, and ECTD Submission." International Journal of Creative and Open Research in Engineering and Management, vol. 02, no. 8, 2026, pp. 1-9. doi:https://doi.org/10.55041/ijcope.v2i8.121.

Swetha, Vadapally,Nagilla Rajitha, and Chada Sravanthi. "Pharmaceutical Regulatory Affairs: Regulatory Functions, CTD Requirements, and ECTD Submission." International Journal of Creative and Open Research in Engineering and Management 02, no. 8 (2026): 1-9. https://doi.org/https://doi.org/10.55041/ijcope.v2i8.121.

Search & Index

References

Nazia Begam, Kotra Chandrasekhar Rangaiah, Bodupally Anusha, Manikeswari, Shakapuram Shailaja; FORMULATION, EVALUATION AND OPTIMIZATION NANOSPONGES OF ISAVUCONAZOLE ;International Journal of Pharmaceutical Science and Hhealth Care;RS Publication; 2026: vol 16(3);pages 6.

Bodupally Anusha Kotra Chandrasekhar Rangaiah,Shakapuram Shailaja, Manikeswari; Formulation and Evaluation of Pitavastatin Self-Nanoemulsifying Drug Delivery System; International Journal of Pharmaceutical Science and Health Car;RS Publication; 2026: vol 16(3);pages 20.

Sunil Kumar Avadhuta Pragathi, Dr. K. Chandrasekhar Rangaiah, Sravanthi Chada;FORMULATION AND EVALUATION OF VALSARTAN SR MATRIX TABLETS; Journal for Innovative Development in Pharmaceutical and Technical Science2025;vol 8(10);pages 8.

Dumpala Swathi, Dr. K. Chandrasekhar Rangaiah; DESIGN AND CHARACTERIZATION OF RESERPIDONE MINI TABLETS;Journal for Innovative Development in Pharmaceutical and Technical Science; 2025; vol 8(10);pages 10.

Priya Mounika, Dr K. Chandrasekhar Rangaiah, Sravanthi Chada, M. Sunil Kumar;FORMULATION AND EVALUATION OF CELECOXIB COLON SPECIFIC DELIVERY;Journal For Innovative Development in Pharmaceutical and Technical Science;2025;vol 8(10);pages 10

Lishetty Haritha Devi, M.Sunil Kumar, Dr. K. Chandrasekhar Rangaiah;Lishetty Haritha Devi, M.Sunil Kumar, Dr. K. Chandrasekhar Rangaiah;International Research Journal of Modernization in Engineering Technology and Science;2024;vol 6(9);pages 8.

Rekulampadu Sushma, M. Sunil Kumar, Dr. K, Chandrasekhar Rangaiah; A COMPARATIVE EVALUATION OF ANTI-UROLITHIATIC POTENSTIAL OF CLEOME VISCOSA, PSIDIUM GUAJAVA, MIRABILIS JALAPA, AND COCOS NUCIFERA LEAF EXTRACTS; International Research Journal of Modernization in Engineering Technology and Science;2024;vol 6(9);pages 11

Racha Spandana, Puli Ramya Krishna, K Chandrasekhar Rangaiah, Sravanthi Chada, Shakapuram Shailaja, Suchitra Duddagi;Racha Spandana, Puli Ramya Krishna, K Chandrasekhar Rangaiah, Sravanthi Chada, Shakapuram Shailaja, Suchitra Duddagi; Journal of Global Trends in Pharmaceutical Sciences;2024;vol 15(3);pages 5

Kotra Chandrasekhar Rangaiah, Punna V. Darshanam;Green approach method development and validation by QBD-Based Liquid Chromatograhic Method for Estimation of Favipiravir;African Journal of Biological Sciences;2024;vol 6(15);pages 10

KRISHNA BHAVANI, Dr. KOTRA CHANDRASEKHAR RANGAIAH; INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES; INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES;csk publishers;2024; vol 11(9);pages 13

Ethical Compliance & Review Process

•All submissions are screened under plagiarism detection.
•Review follows editorial policy.
•Authors retain copyright.
•Peer Review Type: Double-Blind Peer Review
•Published on: Aug 14 2026

CCBYNC

This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. You are free to share and adapt this work for non-commercial purposes with proper attribution.

View License

Back to Volume 02, Issue 8 View All Issues Next Article

← Previous Article

Osteoporosis and Ayurveda: A Comprehensive Review of Pathogenesis, Modern Management, and Traditional Perspectives

Next Article →

Political unrest in Pakistan-Occupied Kashmir: Democratic Legitimacy, Governance, and Regional Security in a Contested Territory.