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Drug Regulatory Affairs Dr. N. S. Vyawahare
Drug Regulatory Affairs
Dr. N. S. Vyawahare
Regulatory Affair and its Importance - Drug Discover and Development - Regulatory Strategy - Investigational New Drug Application IND - New Drug Application NDA - Abbreviated New Drug Application ANDA - Drug Master File DMF - Orphan Drug - Biological Licensing Application BLA - Registrationa of Drug Products in Overseas Markets Pharmaceutical export - Regulatory Authorities and Agencies - Overview of Drug and Cosmetic Act - Regulatory Guidelines - Useful Information
| Media | Books Paperback Book (Book with soft cover and glued back) |
| Released | July 4, 2005 |
| ISBN13 | 9789380064680 |
| Publishers | Nirali Prakashan, Educational Publishers |
| Pages | 324 |
| Dimensions | 189 × 246 × 17 mm · 580 g |
| Language | English |