{"id":140370,"date":"2019-11-11T20:34:23","date_gmt":"2019-11-12T03:34:23","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/regulatorische-dienstleistungen-fuer-asien\/regulierungsstrategie-in-asien\/"},"modified":"2022-05-10T05:27:22","modified_gmt":"2022-05-10T12:27:22","slug":"regulierungsstrategie-in-asien","status":"publish","type":"page","link":"https:\/\/lifesciences.csoftintl.com\/de\/regulierungsstrategie-in-asien\/","title":{"rendered":"Regulierungsstrategie in Asien"},"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 title=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IiIsImFmdGVyIjoiIn19@” button_one_text=”Treten Sie jetzt mit uns in Kontakt” button_one_url=”https:\/\/lifesciences.csoftintl.com\/contact\/” 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″ _dynamic_attributes=”title” title_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\/2019\/11\/X2-China-Regulatory-Strategy-pc-banner.jpg” parallax=”on” parallax_method=”on” custom_button_two=”on” button_two_icon=”%%34%%” button_two_on_hover=”off” custom_margin=”|||” custom_padding=”150px||80px|” custom_padding_tablet=”” custom_padding_phone=”50px||50px|” custom_padding_last_edited=”on|desktop” 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

CSOFT\u2019s expert Asia regulatory strategy consultants provide our clients with insight into China\u2019s pharmaceutical industry and help strategize regulatory and commercialization plans. We strive to ease complex issues our clients are facing such as obtaining the NMPA\u2019s approval to register as well as to incorporate new medical products into China’s market.<\/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=”0px|0px|0px|0px”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”on|on|off” admin_label=”Is this your challenge” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”20px” header_3_text_align=”center” max_width=”78%” module_alignment=”center” custom_padding=”50px||50px|” custom_css_main_element=”columns: 2;||column-width: 300px;”]<\/p>\n

Before introducing new drugs into the Chinese market, companies must obtain approval from NMPA and create proper pricing and branding for the products. Our Asia regulatory strategy experts will work directly with your team to perform a comprehensive analysis and evaluate business opportunities versus risk factors.<\/p>\n

The consultant team will give our clients specific guidelines on how to register their medical products and obtain faster approval from the NMPA. Afterward, we will\u00a0design\u00a0a plan to\u00a0launch\u00a0the product into China’s market and assist its implementation.\u00a0Our team\u00a0is dedicated to minimizing our clients’ risk while maximizing their business value and profits.<\/p>\n

[\/et_pb_text][\/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=”0|0px||0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_code _builder_version=”3.17.6″]<\/p>\n

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[\/et_pb_code][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_margin=”||” custom_padding=”0px||”][et_pb_row _builder_version=”3.25″ custom_margin=”||0px” custom_padding=”||0px” locked=”off”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”3.27.4″ header_font=”||||||||” header_2_font=”||||||||” header_2_text_align=”center”]<\/p>\n

Registrierung von Medizinprodukten<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ custom_margin=”||0px” custom_padding=”||0px”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/11\/Medical-Product-Registration-chart-001.jpg” alt=”The complexity of Asia Regulatory Strategy” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″][\/et_pb_image][\/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=”10px|0px|0|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_code _builder_version=”3.17.6″]<\/p>\n

<\/div>\n

[\/et_pb_code][\/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” locked=”off”][et_pb_row _builder_version=”3.25″ locked=”off”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ header_font=”||||||||” header_2_font=”||||||||” header_2_text_align=”center”]<\/p>\n

Clinical Trials in Asia: Methodology<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” module_alignment=”center” custom_padding=”25.5938px|0px|0|0px|false|false”][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”on|on|off” module_class=”checkalign-right” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” header_3_font=”||||||||” header_3_text_align=”right” text_orientation=”right” hover_enabled=”0″ custom_css_main_element=”#main-content .et_pb_text.checkalign-right li::before {content: ‘N’;|| margin-right: 0px;|| position: absolute;|| right: 0px;|| font: 20px ‘ETmodules’;|| color: #2ea3f2;|| padding-right: 20px;||}||#main-content .et_pb_text.checkalign-right li {|| padding-right: 10px;|| line-height: 1.2em;|| margin-bottom: 20px;|| font-size: 17px;||}”]<\/p>\n

Research<\/h3>\n
    \n

    Data analytics & evaluation skills<\/p>\n

    Product gap analysis<\/p>\n

    Access to first-hand
    \nmarket data & intelligence<\/p>\n

    Access to first-hand
    \nmarket data & intelligence<\/p>\n

    Deliverables<\/h3>\n

    Market research reports<\/p>\n

    Data summaries<\/p>\n

    Proposals<\/p>\n

    Comments & feedback<\/p>\n

    [\/et_pb_text][\/et_pb_column][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\/2019\/11\/cirle-chart.jpg” alt=”Clinical trials in Asia” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ custom_padding=”50px||”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”on|on|off” module_class=”check-list-box” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” header_3_font=”||||||||” header_3_text_align=”left” hover_enabled=”0″]<\/p>\n

    Consulting<\/h3>\n

    Medical market<\/p>\n

    Healthcare system<\/p>\n

    Pharmaceutical regulations<\/p>\n

    Latest updates and revisions to regulations<\/p>\n

    Cultural and linguistic differences<\/p>\n

    Communications<\/h3>\n

    RA executives<\/p>\n

    International marketing and sales team<\/p>\n

    Key opinion leaders (KOLs)<\/p>\n

    Local experts in NMPA regulations and clinical trials in China market<\/p>\n

    [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=” CONTACT US BOTTOM” module_id=”Kontakt” _builder_version=”3.22″ custom_padding=”31px|0px|49px|0px|false|false” top_divider_color=”#eee07c” top_divider_height=”73px” top_divider_flip=”horizontal” top_divider_height_tablet=”52px” top_divider_height_phone=”52px” top_divider_height_last_edited=”on|phone” bottom_divider_style=”wave2″ bottom_divider_color=”rgba(0,0,0,0.5)” bottom_divider_flip=”horizontal|vertical”][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

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