[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”3.22″ custom_margin=”|||” custom_padding=”0px|0px|0px|0px”][et_pb_fullwidth_header button_one_text=”Treten Sie jetzt mit uns in Kontakt” button_one_url=”https:\/\/lifesciences.csoftintl.com\/de\/kontakt\/” background_overlay_color=”rgba(0,0,0,0.66)” content_max_width=”80%” 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=”||||||||” 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\/2020\/07\/interpretation-cde-cder-bg1.jpg” parallax=”on” parallax_method=”on” custom_button_two=”on” button_two_icon=”%%34%%” button_two_on_hover=”off” custom_margin=”|||” custom_padding=”130px||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
[\/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″ background_color=”#ffffff” custom_padding=”0|0px|21px|0px|false|false”][et_pb_row _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” column_structure=”2_5,3_5″][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/03\/MedicalWriting-3-1.jpg” align=”center” align_tablet=”center” align_last_edited=”on|desktop” _builder_version=”3.23″ max_width=”94%”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”left” custom_margin=”||||false|false” hover_enabled=”0″]<\/p>\n
The NMPA\u2019s Center for Drug Evaluation and Research (CDE) regulates the entry of over-the-counter and prescription drugs into China\u2019s pharmaceutical market, including biological therapeutics and generic drugs already approved by other regulatory bodies, such as the U.S.\u2019 Food and Drug Administration (FDA). Pre-application Investigational New Drug (IND)\/New Drug Application (NDA) meetings with the CDE can help establish a relationship between life science companies and the regulatory agency before approval.\u00a0CSOFT Health Sciences\u2019 expertise in interpreting and medical translation can ensure\u00a0accurate and timely multilingual communication for every CDE meeting.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_color=”#ffffff” background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/03\/medical-bg1.jpg” custom_padding=”35px|0px|94px|0px|false|false” hover_enabled=”0″ title_text=”medical-bg1″][et_pb_row _builder_version=”3.25″ custom_padding=”0||0||false|false” column_structure=”3_5,2_5″][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” admin_label=”Other Interpretation Services” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”left” custom_margin=”50px|||” hover_enabled=”0″]<\/p>\n
INDs and NDAs are notoriously a timely and costly process. Scheduling an advance meeting can help:<\/p>\n
While CDE pre-IND\/NDA meetings are not necessarily required, they can help save time, money, and energy in the regulatory approval process. To ensure an effective meeting, CSOFT Health Sciences\u2019 high-quality and accurate translation is essential for clear communication and understanding between both parties.[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_color=”#ffffff” custom_padding=”0|0px|21px|0px|false|false”][et_pb_row _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”0px||0px”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”left” custom_margin=”50px|||” hover_enabled=”0″]<\/p>\n
CSOFT\u00a0Health Sciences\u2019\u00a0linguistic experts provide interpretation for your CDE meetings live on-site or remotely, assuring the quality, speed, and effectiveness of your communication. With in-depth knowledge of China\u2019s regulatory body and requirements, we ensure that you are more than prepared for the meeting\u00a0and able to petition\u00a0for the best possible outcome for your medical device or drug therapy, all while providing expert translation solutions throughout the process.<\/p>\n
Learn more<\/u><\/a><\/span>\u00a0about our consulting and translation services for the NMPA.[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ column_structure=”3_5,2_5″][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” module_class=”check-list-box” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_3_text_align=”center” custom_padding=”30px||” hover_enabled=”0″]<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/interpretationscde-cder-1.jpeg” align=”center” align_tablet=”center” align_last_edited=”on|desktop” _builder_version=”3.23″ max_width=”94%”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_color=”#ffffff” background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/CDECDER-2.jpg” custom_padding=”35px|0px|94px|0px|false|false” hover_enabled=”0″][et_pb_row _builder_version=”3.25″ custom_padding=”0||0||false|false” column_structure=”1_2,1_2″][et_pb_column type=”1_2″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” module_class=”check-list-box” _builder_version=”4.5.3″ text_font=”||||||||” header_3_text_align=”center” hover_enabled=”0″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_color=”#f9f9f9″ custom_padding=”0|0px|0px|0px|false|false” locked=”off”][et_pb_row column_structure=”1_3,2_3″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px|0px|60px|0px” global_module=”175790″ saved_tabs=”all”][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/03\/ISO-2022-white.png” alt=”ISO-certified Academic Translations” title_text=”ISO-2022-white” align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ max_width=”100%” custom_padding=”100px||||false|false”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]\n\n\n \nWith over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of\u00a0data\u00a0security to our clients,\u00a0and we take nothing for granted when confidentiality is a concern.\u00a0Our well-documented and fully traceable information data security policies, checklists, and quality records leverage best practices of ISO 27001<\/b><\/strong>, and are designed to keep everything from source data to\u00a0translations protected. From our 24\/7\/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.\n<\/p>\n \nLearn more\u00a0about how CSOFT\u00a0prioritizes\u00a0data security<\/u><\/a><\/span>.\n<\/p>\n \n\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_enable_color=”off” custom_padding=”0|0px|0px|0px|false|false” locked=”off”][et_pb_row column_structure=”2_3,1_3″ _builder_version=”4.5.3″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px|0px|60px|0px” border_width_top=”1px” border_color_top=”#cccccc” global_module=”175789″ saved_tabs=”all”][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]\n\n\n \nCSOFT Health Sciences has\u00a0developed a process for quality assurance to ensure that every medical translation\u00a0project meets quality standards in a cost-effective and timely manner. We are certified in\u00a0ISO 17100:2015<\/b><\/strong>,\u00a0ISO 9001:2015<\/b><\/strong>, and\u00a0ISO 13485:2016<\/b><\/strong>\u00a0<\/b><\/strong>to ensure our customized solutions meet global regulatory requirements. Our\u00a0subject matter expert linguists have a minimum of 7 years\u2019 experience and work with in-country reviewers and project style guides to meet industry standards.\u00a0And\u00a0through our\u00a0innovative cloud-based technology<\/u><\/a><\/span>, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time.\u00a0Every step of the way, CSOFT has you covered.\n\n<\/p>\nWe interpret:<\/h4>\n
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Other Interpretation Services<\/h4>\n
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Data Security<\/h2>\n
Quality Assurance<\/h2>\n