{"id":140077,"date":"2019-10-21T23:51:22","date_gmt":"2019-10-22T06:51:22","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/presentacion-ctd-ectd\/"},"modified":"2023-02-17T01:46:58","modified_gmt":"2023-02-17T08:46:58","slug":"presentacion-ctd-ectd","status":"publish","type":"page","link":"https:\/\/lifesciences.csoftintl.com\/es\/presentacion-ctd-ectd\/","title":{"rendered":"Presentaci\u00f3n CTD\/eCTD"},"content":{"rendered":"

[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”3.22″ custom_margin=”|||” custom_padding=”0px|0px|3px|0px|false|false”][et_pb_fullwidth_header button_one_text=”Cont\u00e1ctenos ahora” button_one_url=”https:\/\/lifesciences.csoftintl.com\/es\/contacto\/” background_overlay_color=”rgba(0,0,0,0)” content_max_width=”59%” content_max_width_tablet=”” content_max_width_phone=”” content_max_width_last_edited=”on|desktop” module_class=”hide-h1″ _builder_version=”4.5.3″ content_font_size=”22px” content_line_height=”1.9em” background_color=”rgba(255, 255, 255, 0)” background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2021\/12\/CTDeCTD-Submissions-banner-min.jpg” custom_button_two=”on” button_two_font=”||||||||” button_two_icon=”%%34%%” button_two_on_hover=”off” custom_margin=”|||” custom_padding=”40px||80px|” custom_padding_tablet=”” custom_padding_phone=”50px||50px|” custom_padding_last_edited=”on|desktop” hover_enabled=”0″ content_font_size_tablet=”” content_font_size_phone=”17px” content_font_size_last_edited=”on|desktop” button_one_text_size__hover_enabled=”off” button_one_text_size__hover=”null” button_two_text_size__hover_enabled=”off” button_two_text_size__hover=”null” button_one_text_color__hover_enabled=”off” button_one_text_color__hover=”null” button_two_text_color__hover_enabled=”off” button_two_text_color__hover=”null” button_one_border_width__hover_enabled=”off” button_one_border_width__hover=”null” button_two_border_width__hover_enabled=”off” button_two_border_width__hover=”null” button_one_border_color__hover_enabled=”off” button_one_border_color__hover=”null” button_two_border_color__hover_enabled=”off” button_two_border_color__hover=”null” button_one_border_radius__hover_enabled=”off” button_one_border_radius__hover=”null” button_two_border_radius__hover_enabled=”off” button_two_border_radius__hover=”null” button_one_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover=”null” button_two_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover=”null” button_one_bg_color__hover_enabled=”off” button_one_bg_color__hover=”null” button_two_bg_color__hover_enabled=”off” button_two_bg_color__hover=”null”]<\/p>\n

CTD and eCTD Translations<\/h1>\n

We offer comprehensive CTD and eCTD translations to help you to easily create files that comply with the latest regulatory guidelines<\/p>\n

[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”23px|0px|0|0px|false|false”][et_pb_row _builder_version=”3.25″ custom_padding=”0|0px|0|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][divienhancer_breadcrumb _builder_version=”3.20.2″][\/divienhancer_breadcrumb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”0|0px|0|0px|false|false”][et_pb_row _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”40px|0px|40px|0px”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” admin_label=”Is this your challenge” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”center” custom_padding=”10px||10px||false|false” hover_enabled=”0″ header_2_text_align=”center”]<\/p>\n

End-to-End Common Technical Document Translations<\/h2>\n

The Common Technical Document\u00a0(CTD), as well as its electronic counterpart, the\u00a0eCTD, is a collection of information about a drug\u2019s\u00a0overall quality, toxicology, and safety and efficacy,\u00a0that is submitted to regulatory authorities such as the FDA, EMA, NMPA, and Health Canada\u00a0when compiling applications for new drugs, making CTD and eCTD translations\u00a0essential for companies bringing\u00a0new medications to market. As the world becomes increasingly digital, the eCTD\u00a0has emerged as a way to pursue harmonization in electronic submissions of the CTD. Both the CTD and eCTD are composed of five modules. While Module 1 is technically region-specific and not an official part of the CTD, Modules 2-5 cover\u00a0clinical and nonclinical data,\u00a0including quality, toxicology and pharmacology reports, and clinical trial\u00a0reports.<\/p>\n

As the demand for pharmaceutical products increases globally, the need for CTD and eCTD translations are growing. Because CTDs and eCTDs\u00a0are highly specialized documents with high volume and tight deadlines, finding the right localization\u00a0partner to translate them accurately and efficiently is vital. Mistakes in translation, incorrect formatting,\u00a0or missed deadlines can increase time to market, potentially costing pharmaceutical companies millions in lost revenue. To help companies navigate this challenge, CSOFT\u00a0Health Sciences\u2019\u00a0global network and of 10,000+ native linguists\u00a0and\u00a0CTD\u00a0and eCTD subject matter experts\u00a0with familiarity in all modules, including CMC, PK\/PD, Toxicology, Clinical Written, and Tabulated Summaries, CTD formatting services, and technology driven systems provides life science companies with highly accurate and time efficient\u00a0CTD\u00a0and eCTD translations in over 250 languages.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2021\/12\/Our-Methodology-min.jpg” parallax=”on”][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” admin_label=”Our Methodology” _builder_version=”4.5.3″ text_font_size=”16px” custom_margin=”||20px|” hover_enabled=”0″]<\/p>\n

Our Methodology for CTD and eCTD Translations<\/h2>\n

CSOFT Health Sciences has an over\u00a010,000-strong network of industry\u00a0experienced linguists, professional in-country reviewers, cultural experts, and desktop publishing engineers that are ready to deliver medical translation and localization solutions for regulatory submissions. CSOFT is specialized in CTD translation projects, and our professional team has in-depth knowledge of recent\u00a0FDA, EMA, TGA, and\u00a0NMPA policy reforms, as well as\u00a0regulatory requirements<\/u><\/a><\/span>. In addition, we have a stringent quality control methodology for\u00a0dossier translations<\/u><\/a><\/span>\u00a0designed for helping\u00a0global drug developers mitigate risk while seeking approval from global regulatory bodies.<\/p>\n

Learn more\u00a0about the methodologies we employ<\/u><\/a><\/span>.<\/p>\n

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Regulation-Compliant Formatting for CTD and eCTD Submissions<\/h2>\n

Regulatory authorities have strict requirements for CTD and eCTD submissions\u00a0which extends to language requirements\u00a0and translations. If documents are not properly formatted, pharmaceutical companies may experience delays in time to market, leading to serious revenue losses. CSOFT\u00a0Health Sciences\u2019\u00a0team of desktop publishing\u00a0(DTP)\u00a0engineers\u00a0provide regulation-compliant formatting support\u00a0to ensure on-time submission for\u00a0the best ROI for pharmaceutical companies. Specifically, CSOFT\u2019s team of DTP engineers can provide the following formatting services for CTD and eCTD submissions:<\/p>\n

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