An Insight to Drug Regulatory Affairs | As per PCI Syllabus | Dr. Hemant Keshavrao | Birla Publications Pvt. Ltd. | 3D Edition

*An Insight to Drug Regulatory Affairs | As per PCI Syllabus | Dr. Hemant Keshavrao | Birla Publications Pvt. Ltd. | 3D Edition*

*Key Features:*
- *PCI Syllabus Based*: Written strictly as per Drug Regulatory Affairs syllabus for http://D.Pharm under PCI ER-2020
- *Regulatory Framework*: Covers drug approval process, regulatory authorities like CDSCO, FDA, EMA, and WHO guidelines
- *Documentation & Filing*: Explains Dossier preparation, CTD format, DMF, ANDA, NDA, and regulatory submissions
- *Acts & Guidelines*: Details Drugs and Cosmetics Act, Schedule M, Schedule Y, GMP, GLP, and ICH guidelines
- *Quality & Compliance*: Includes pharmacovigilance, post-marketing surveillance, and drug recall procedures
- *Industry Oriented*: Practical insights into licensing, import-export regulations, and clinical trial approval process
- *Exam Focused*: Simplified language with flowcharts, tables, and important questions for http://D.Pharm exams
- *3D Technology*: Enhanced with 3D visuals for better understanding of complex regulatory processes
- *Recommended Read*: Published by Birla Publications Pvt. Ltd., ideal for http://D.Pharm students and pharma professionals

A must-have guide for http://D.Pharm students to understand the complete drug regulatory landscape and build careers in regulatory affairs.