{"title":"NDA, Guides, D.Pharmacy","description":null,"products":[{"product_id":"an-insight-to-drug-regulatory-affairs-as-per-pci-syllabus-dr-hemant-keshavrao-birla-publications-pvt-ltd-3d-edition","title":"An Insight to Drug Regulatory Affairs | As per PCI Syllabus | Dr. Hemant Keshavrao | Birla Publications Pvt. Ltd. | 3D Edition","description":"\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e*An Insight to Drug Regulatory Affairs | As per PCI Syllabus | Dr. Hemant Keshavrao | Birla Publications Pvt. Ltd. | 3D Edition*\u003c\/p\u003e\n\u003cp\u003e*Key Features:*\u003cbr\u003e- *PCI Syllabus Based*: Written strictly as per Drug Regulatory Affairs syllabus for http:\/\/D.Pharm under PCI ER-2020\u003cbr\u003e- *Regulatory Framework*: Covers drug approval process, regulatory authorities like CDSCO, FDA, EMA, and WHO guidelines\u003cbr\u003e- *Documentation \u0026amp; Filing*: Explains Dossier preparation, CTD format, DMF, ANDA, NDA, and regulatory submissions\u003cbr\u003e- *Acts \u0026amp; Guidelines*: Details Drugs and Cosmetics Act, Schedule M, Schedule Y, GMP, GLP, and ICH guidelines\u003cbr\u003e- *Quality \u0026amp; Compliance*: Includes pharmacovigilance, post-marketing surveillance, and drug recall procedures\u003cbr\u003e- *Industry Oriented*: Practical insights into licensing, import-export regulations, and clinical trial approval process\u003cbr\u003e- *Exam Focused*: Simplified language with flowcharts, tables, and important questions for http:\/\/D.Pharm exams\u003cbr\u003e- *3D Technology*: Enhanced with 3D visuals for better understanding of complex regulatory processes\u003cbr\u003e- *Recommended Read*: Published by Birla Publications Pvt. Ltd., ideal for http:\/\/D.Pharm students and pharma professionals\u003c\/p\u003e\n\u003cp\u003eA must-have guide for http:\/\/D.Pharm students to understand the complete drug regulatory landscape and build careers in regulatory affairs.\u003c\/p\u003e","brand":"New Vidyasagar Book Mart","offers":[{"title":"Default Title","offer_id":53437990175017,"sku":null,"price":220.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0867\/4367\/9273\/files\/rn-image_picker_lib_temp_73743df5-9dbc-48d4-b57e-32ad914cb77e.jpg?v=1787153091"}],"url":"https:\/\/www.onetouchbook.com\/collections\/nda-guides-d-pharmacy.oembed","provider":"OneTouch Book","version":"1.0","type":"link"}