Drug Regulatory Affairs



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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



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