{"product_id":"regulatory-affairs-in-the-pharmaceutical-industry","title":"Regulatory Affairs in the Pharmaceutical Industry","description":"\u003cp\u003e\u003ci\u003eRegulatory Affairs in the Pharmaceutical Industry\u003c\/i\u003e is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application).\u003c\/p\u003e \u003cp\u003eChapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.\u003c\/p\u003e \u003cbr\u003e\u003cbr\u003e\u003cul\u003e \u003cli\u003eUpdated reference on drug approval processes in key global markets\u003c\/li\u003e \u003cli\u003eProvides comprehensive coverage of concepts and regulatory affairs\u003c\/li\u003e \u003cli\u003ePresents a concise compilation of the regulatory requirements of different countries\u003c\/li\u003e \u003cli\u003eIntroduces the fundamentals of manufacturing controls and their regulatory importance\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Elsevier Science","offers":[{"title":"Default Title","offer_id":48115575718078,"sku":null,"price":200.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0536\/0592\/5054\/files\/17452123482233.jpg?v=1783634301","url":"https:\/\/bookshopnow.com\/products\/regulatory-affairs-in-the-pharmaceutical-industry","provider":"Book Shop Now","version":"1.0","type":"link"}