{"title":"CMC Templates","description":"\u003ch3 style=\"text-align: center;\"\u003e\n\u003cspan style=\"background-color: rgb(0, 0, 0);\"\u003eWelcome to \u003c\/span\u003e\u003cbr\u003e\u003cspan style=\"background-color: rgb(0, 0, 0);\"\u003e\u003cstrong\u003eDocument Quality (CMC)*!\u003c\/strong\u003e\u003c\/span\u003e\n\u003c\/h3\u003e\n\u003ch4\u003e\u003cbr\u003e\u003c\/h4\u003e\n\u003ch4 style=\"text-align: justify;\"\u003e\n\u003cspan style=\"background-color: rgb(0, 0, 0);\"\u003eAs a more affordable \u003cstrong\u003eDocument Quality (CMC)*\u003c\/strong\u003e option, the products listed here are CMC templates that can be \u003c\/span\u003eused for your drug product. Please keep in mind that template documents will provide suggestions on the information you should provide in your\u003cstrong\u003e IND, NDA,\u003c\/strong\u003e or \u003cstrong\u003eANDA\u003c\/strong\u003e.\u003c\/h4\u003e\n\u003ch4 style=\"text-align: justify;\"\u003e\u003cstrong\u003e\u003cem\u003eFor your security and mine, I am using shopify as I trust this site in handling financial payments. I accept all payments that are listed below (in the footer of this page).\u003c\/em\u003e\u003c\/strong\u003e\u003c\/h4\u003e\n\u003ch4 style=\"text-align: left;\"\u003e\u003cstrong\u003e*Chemistry, Manufacturing, and Controls\u003c\/strong\u003e\u003c\/h4\u003e\n\u003ch4 style=\"text-align: justify;\"\u003e(\u003cspan style=\"text-decoration: underline;\"\u003ePlease Note\u003c\/span\u003e: The incompleteness of the document(s) (i.e. template[s]) is reflected in the product price below.)\u003c\/h4\u003e","products":[{"product_id":"template-qos-dp","title":"[TEMPLATE] 2.3.P Quality Overall Summary - Drug Product","description":"\u003ch3 style=\"text-align: left;\"\u003eWelcome to\u003cstrong\u003e Document Quality (CMC)*\u003c\/strong\u003e!\u003c\/h3\u003e\n\u003ch4 style=\"text-align: left;\"\u003e\u003cstrong\u003eShop for CMC templates here!\u003c\/strong\u003e\u003c\/h4\u003e\n\u003ch4 style=\"text-align: left;\"\u003e\u003cstrong\u003e[TEMPLATE] 2.3.P Quality Overall Summary - Drug Product\u003c\/strong\u003e\u003c\/h4\u003e\n\u003ch4 style=\"text-align: left;\"\u003eThis \u003cstrong\u003e2.3.P Quality Overall Summary - Drug Product\u003c\/strong\u003e \u003cspan style=\"text-decoration: underline;\"\u003e\u003cstrong\u003etemplate\u003c\/strong\u003e\u003c\/span\u003e contains the following sections (in a single document):\u003cbr\u003e\u003cbr\u003e-2.3.P.1 Description and Composition of the Drug Product\u003cbr\u003e-2.3.P.2 Pharmaceutical Development\u003cbr\u003e-2.3.P.3 Manufacture\u003cbr\u003e-2.3.P.4 Control of Excipients\u003cbr\u003e-2.3.P.5 Control of Drug Product\u003cbr\u003e-2.3.P.6 Reference Standards or Materials\u003cbr\u003e-2.3.P.7 Container Closure System\u003cbr\u003e-2.3.P.8 Stability\u003c\/h4\u003e\n\u003ch4 style=\"text-align: left;\"\u003eThis \u003cstrong\u003e2.3.P Quality Overall Summary - Drug Product\u003c\/strong\u003e \u003cspan style=\"text-decoration: underline;\"\u003e\u003cstrong\u003etemplate\u003c\/strong\u003e\u003c\/span\u003e can be used to further develop the \u003cstrong\u003eModule 3 Section 3.2.P Drug Product \u003c\/strong\u003eSection. Please note that the \u003cstrong\u003eModule 3 Section 3.2.P Drug Product \u003c\/strong\u003eSection should contain the following sections (in 8 separate documents):\u003cbr\u003e\u003cbr\u003e-3.2.P.1 Description and Composition of the Drug Product\u003cbr\u003e-3.2.P.2 Pharmaceutical Development\u003cbr\u003e-3.2.P.3 Manufacture\u003cbr\u003e-3.2.P.4 Control of Excipients\u003cbr\u003e-3.2.P.5 Control of Drug Product\u003cbr\u003e-3.2.P.6 Reference Standards or Materials\u003cbr\u003e-3.2.P.7 Container Closure System\u003cbr\u003e-3.2.P.8 Stability\u003c\/h4\u003e\n\u003ch4 style=\"text-align: left;\"\u003e\u003cstrong\u003e*Chemistry, Manufacturing, and Controls\u003c\/strong\u003e\u003c\/h4\u003e","brand":"My Store","offers":[{"title":"Default Title","offer_id":41464711807031,"sku":null,"price":30.0,"currency_code":"USD","in_stock":true}]},{"product_id":"template-qos-ds","title":"[TEMPLATE] 2.3.S Quality Overall Summary - Drug Substance","description":"\u003ch3 style=\"text-align: left;\"\u003eWelcome to \u003cstrong\u003eDocument Quality (CMC)*\u003c\/strong\u003e!\u003c\/h3\u003e\n\u003ch4 style=\"text-align: left;\"\u003e\u003cstrong\u003eShop for CMC templates here!\u003c\/strong\u003e\u003c\/h4\u003e\n\u003ch4 style=\"text-align: left;\"\u003e\u003cstrong\u003e[TEMPLATE] 2.3.S Quality Overall Summary \u003c\/strong\u003e\u003c\/h4\u003e\n\u003ch4 style=\"text-align: left;\"\u003eThis \u003cstrong\u003e2.3.S Quality Overall Summary - Drug Substance\u003c\/strong\u003e \u003cspan style=\"text-decoration: underline;\"\u003e\u003cstrong\u003etemplate\u003c\/strong\u003e\u003c\/span\u003e contains the following sections (in a single document):\u003c\/h4\u003e\n\u003ch4 style=\"text-align: left;\"\u003e-2.3.S.1 General Information\u003cbr\u003e-2.3.S.2 Manufacture\u003cbr\u003e-2.3.S.3 Characterization\u003cbr\u003e-2.3.S.4 Control of Drug Substance\u003cbr\u003e-2.3.S.5 Reference Standards or Materials\u003cbr\u003e-2.3.S.6 Container Closure System\u003cbr\u003e-2.3.S.7 Stability\u003c\/h4\u003e\n\u003ch4 style=\"text-align: left;\"\u003eThis \u003cstrong\u003e2.3.S Quality Overall Summary - Drug Substance\u003c\/strong\u003e \u003cspan style=\"text-decoration: underline;\"\u003e\u003cstrong\u003etemplate\u003c\/strong\u003e\u003c\/span\u003e can be used to further develop the \u003cstrong\u003eModule 3 Section 3.2.S Drug Substance\u003c\/strong\u003e Section. Please note that the \u003cstrong\u003eModule 3 Section 3.2.S Drug Substance\u003c\/strong\u003e Section should contain the following sections (in 7 separate documents):\u003c\/h4\u003e\n\u003ch4 style=\"text-align: left;\"\u003e-3.2.S.1 General Information\u003cbr\u003e-3.2.S.2 Manufacture\u003cbr\u003e-3.2.S.3 Characterization\u003cbr\u003e-3.2.S.4 Control of Drug Substance\u003cbr\u003e-3.2.S.5 Reference Standards or Materials\u003cbr\u003e-3.2.S.6 Container Closure System\u003cbr\u003e-3.2.S.7 Stability\u003c\/h4\u003e\n\u003ch3 style=\"text-align: left;\"\u003e\u003cstrong\u003e*Chemistry, Manufacturing, and Controls\u003c\/strong\u003e\u003c\/h3\u003e","brand":"My Store","offers":[{"title":"Default Title","offer_id":41464712003639,"sku":null,"price":30.0,"currency_code":"USD","in_stock":true}]}],"url":"https:\/\/document-quality.myshopify.com\/collections\/templatecmc.oembed","provider":"Document Quality (Chemistry, Manufacturing, and Controls)","version":"1.0","type":"link"}