﻿{"id":21554,"date":"2018-09-25T12:08:16","date_gmt":"2018-09-25T04:08:16","guid":{"rendered":"https:\/\/cdmocmo.ribobio.com\/development\/nda-maa-anda\/"},"modified":"2019-08-23T18:36:04","modified_gmt":"2019-08-23T10:36:04","slug":"nda-maa-anda","status":"publish","type":"page","link":"https:\/\/cdmocmo.ribobio.com\/en\/development\/nda-maa-anda\/","title":{"rendered":"CMC Materials Writing for IND"},"content":{"rendered":"<p>[et_pb_section bb_built=&#8221;1&#8243; _builder_version=&#8221;3.27.2&#8243; background_color=&#8221;#F2F2F2&#8243; custom_padding=&#8221;0px||0px|&#8221; z_index_tablet=&#8221;500&#8243; box_shadow_horizontal_tablet=&#8221;0px&#8221; box_shadow_vertical_tablet=&#8221;0px&#8221; box_shadow_blur_tablet=&#8221;40px&#8221; box_shadow_spread_tablet=&#8221;0px&#8221; _i=&#8221;0&#8243; _address=&#8221;0&#8243; next_background_color=&#8221;#ffffff&#8221; global_module=&#8221;22006&#8243;][et_pb_row global_parent=&#8221;22006&#8243; column_structure=&#8221;1_3,1_3,1_3&#8243; module_class=&#8221;icon_list&#8221; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;||0px|&#8221; _i=&#8221;0&#8243; _address=&#8221;0.0&#8243;][et_pb_column type=&#8221;1_3&#8243; global_parent=&#8221;22006&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221; _i=&#8221;0&#8243; _address=&#8221;0.0.0&#8243;][et_pb_blurb global_parent=&#8221;22006&#8243; url=&#8221;\/en\/development\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon1_0919.png&#8221; module_class=&#8221;icon-quick icon-events&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;0&#8243; _address=&#8221;0.0.0.0&#8243; link_option_url=&#8221;\/en\/development\/&#8221;]<\/p>\n<h6>Oligonucleotide Manufacturing Process Development<\/h6>\n<p>[\/et_pb_blurb][et_pb_blurb global_parent=&#8221;22006&#8243; url=&#8221;\/en\/analytics-and-chemistry-research\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/\u4e34\u5e8a\u7814\u7a76\u7528\u6838\u9178\u836f\u7269\u751f\u4ea7.png&#8221; module_class=&#8221;icon-quick icon-tools&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;1&#8243; _address=&#8221;0.0.0.1&#8243; link_option_url=&#8221;\/en\/analytics-and-chemistry-research\/&#8221;]<\/p>\n<h6>Analytical Methods<br \/> &amp; Stability Study<\/h6>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; global_parent=&#8221;22006&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221; _i=&#8221;1&#8243; _address=&#8221;0.0.1&#8243;][et_pb_blurb global_parent=&#8221;22006&#8243; url=&#8221;\/en\/clinical-nucleic-acid-drug-manufacture\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon3_0919.png&#8221; module_class=&#8221;icon-quick icon-resource&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;0&#8243; _address=&#8221;0.0.1.0&#8243; link_option_url=&#8221;\/en\/clinical-nucleic-acid-drug-manufacture\/&#8221;]<\/p>\n<h6>Oligonucleotide<br \/> Manufacturing for Clinical Phases<\/h6>\n<p>[\/et_pb_blurb][et_pb_blurb global_parent=&#8221;22006&#8243; url=&#8221;\/en\/commercial-oligonucleotides-api-manufacture\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon9_0919.png&#8221; module_class=&#8221;icon-quick icon-buy&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;1&#8243; _address=&#8221;0.0.1.1&#8243; link_option_url=&#8221;\/en\/commercial-oligonucleotides-api-manufacture\/&#8221;]<\/p>\n<h6>Oligonucleotide<br \/> Manufacturing for Commercial Phases<\/h6>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; global_parent=&#8221;22006&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221; _i=&#8221;2&#8243; _address=&#8221;0.0.2&#8243;][et_pb_blurb global_parent=&#8221;22006&#8243; url=&#8221;\/en\/drug-product-fill-and-finish\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon2_0919.png&#8221; module_class=&#8221;icon-quick icon-orders&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;0&#8243; _address=&#8221;0.0.2.0&#8243; link_option_url=&#8221;\/en\/drug-product-fill-and-finish\/&#8221;]<\/p>\n<h6>Preparation, aseptic filling or<br \/> lyophilization<\/h6>\n<p>[\/et_pb_blurb][et_pb_blurb global_parent=&#8221;22006&#8243; url=&#8221;\/en\/quality-management-system\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon8_0919.png&#8221; module_class=&#8221;icon-quick icon-user-center&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;0 |||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;1&#8243; _address=&#8221;0.0.2.1&#8243; link_option_url=&#8221;\/en\/quality-management-system\/&#8221;]<\/p>\n<h6>Validation &amp; Quality<\/h6>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=&#8221;1&#8243; _builder_version=&#8221;3.22&#8243; custom_padding=&#8221;54px|0px|11px|0px&#8221; prev_background_color=&#8221;#F2F2F2&#8243; next_background_color=&#8221;#F4f4f4&#8243;][et_pb_row _builder_version=&#8221;3.25&#8243; border_color_bottom=&#8221;#00AECC&#8221; border_style_bottom=&#8221;none&#8221; custom_margin=&#8221;-30px|||&#8221; custom_padding=&#8221;0||2px|0px&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;3.26.8&#8243; text_text_color=&#8221;#242424&#8243; text_font_size=&#8221;22px&#8221; custom_margin=&#8221;||10px|&#8221; custom_margin_phone=&#8221;|||&#8221; custom_margin_last_edited=&#8221;off|desktop&#8221; custom_padding=&#8221;|||&#8221;]<\/p>\n<h1 style=\"font-size: 22px; padding: 0; color: #1e73be;\"><img loading=\"lazy\" class=\"wp-image-242 alignleft size-full\" src=\"http:\/\/ribobio-test.uin88.com\/wp-content\/uploads\/2018\/04\/shuidi.png\" alt=\"\" width=\"18\" height=\"22\" \/>CMC Materials Writing for IND<\/h1>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;0px|0px|8px|0px|false|false&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;3.26.8&#8243; text_font=&#8221;||||||||&#8221; custom_margin=&#8221;||10px|&#8221;]<\/p>\n<p style=\"text-align: left;\">Providing professional drug registration strategy consulting and implementation services, we have a team of registered experts with years of experience in drug registration and in-depth knowledge of Chinese and international regulations.<\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;3.26.8&#8243; text_font=&#8221;||||||||&#8221; custom_margin=&#8221;||5px|&#8221;]<\/p>\n<p style=\"text-align: left;\"><strong>Our Services<\/strong><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;3.26.8&#8243; custom_margin=&#8221;||15px|&#8221;]<\/p>\n<p style=\"text-align: left;\">\u25cf Compliance with CMC guidance, in line with ICH, CFDA, US FDA and EMA guidelines and other government regulations.<br \/>\u25cf NDA\/MAA &amp; ANDA registration declaration, submission of clinical trial application, registration and commercialization authorization application<br \/>\u25cf Technical data and related information confidentiality services<br \/>\u25cf Effective project management to ensure that your registration application materials are prepared correctly and in a timely manner<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=&#8221;1&#8243; _builder_version=&#8221;3.22&#8243; background_color=&#8221;#F4f4f4&#8243; background_image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/07\/bg_pic3.jpg&#8221; border_width_bottom=&#8221;2px&#8221; border_color_bottom=&#8221;#cccccc&#8221; custom_padding=&#8221;10px|0px|10px|0px|false|false&#8221; prev_background_color=&#8221;#ffffff&#8221; global_module=&#8221;21939&#8243;][et_pb_row global_parent=&#8221;21939&#8243; _builder_version=&#8221;3.26.8&#8243;][et_pb_column type=&#8221;4_4&#8243; global_parent=&#8221;21939&#8243; _builder_version=&#8221;3.26.8&#8243;][et_pb_button global_parent=&#8221;21939&#8243; button_url=&#8221;\/en\/cro-cdmo-service-for-nucleic-acid-drugs\/&#8221; button_text=&#8221;Quote for CDMO service&#8221; button_alignment=&#8221;center&#8221; _builder_version=&#8221;3.26.8&#8243; \/][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[et_pb_section bb_built=&#8221;1&#8243; _builder_version=&#8221;3.27.2&#8243; background_color=&#8221;#F2F2F2&#8243; custom_padding=&#8221;0px||0px|&#8221; z_index_tablet=&#8221;500&#8243; box_shadow_horizontal_tablet=&#8221;0px&#8221; box_shadow_vertical_tablet=&#8221;0px&#8221; 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