{"id":20736,"date":"2023-12-19T08:57:33","date_gmt":"2023-12-19T07:57:33","guid":{"rendered":"https:\/\/ms-c.es\/regulatoria-regulatory-affairs\/"},"modified":"2024-09-10T10:05:48","modified_gmt":"2024-09-10T08:05:48","slug":"regulatory-affairs","status":"publish","type":"page","link":"https:\/\/ms-c.es\/en\/regulatory-affairs\/","title":{"rendered":"Regulatory Affairs"},"content":{"rendered":"[vc_row type=\"in_container\" full_screen_row_position=\"middle\" column_margin=\"none\" column_direction=\"default\" column_direction_tablet=\"default\" column_direction_phone=\"default\" scene_position=\"center\" top_padding=\"70px\" bottom_padding=\"5%\" constrain_group_2=\"yes\" top_padding_tablet=\"10%\" bottom_padding_tablet=\"20%\" text_color=\"dark\" text_align=\"left\" row_border_radius=\"none\" row_border_radius_applies=\"bg\" overflow=\"visible\" class=\"que-hacemos servicio\" id=\"soporte-investigacion\" advanced_gradient_angle=\"0\" overlay_strength=\"0.3\" gradient_direction=\"left_to_right\" shape_divider_position=\"bottom\" bg_image_animation=\"none\" shape_type=\"\" gradient_type=\"default\"][vc_column column_padding=\"no-extra-padding\" column_padding_tablet=\"inherit\" column_padding_phone=\"inherit\" column_padding_position=\"all\" column_element_direction_desktop=\"default\" column_element_spacing=\"default\" desktop_text_alignment=\"default\" tablet_text_alignment=\"default\" phone_text_alignment=\"default\" background_color_opacity=\"1\" background_hover_color_opacity=\"1\" column_backdrop_filter=\"none\" column_shadow=\"none\" column_border_radius=\"none\" column_link_target=\"_self\" column_position=\"default\" gradient_direction=\"left_to_right\" overlay_strength=\"0.3\" width=\"1\/1\" tablet_width_inherit=\"default\" animation_type=\"default\" bg_image_animation=\"none\" border_type=\"simple\" column_border_width=\"none\" column_border_style=\"solid\"][vc_column_text]
MSC<\/a>><\/span>Services<\/a>><\/span>Regulatory Affairs<\/span><\/div>[\/vc_column_text][vc_row_inner column_margin=\"none\" column_direction=\"default\" column_direction_tablet=\"default\" column_direction_phone=\"default\" text_align=\"left\" row_position=\"default\" row_position_tablet=\"inherit\" row_position_phone=\"inherit\" overflow=\"visible\" pointer_events=\"all\"][vc_column_inner column_padding=\"no-extra-padding\" column_padding_tablet=\"inherit\" column_padding_phone=\"inherit\" column_padding_position=\"all\" column_element_direction_desktop=\"default\" column_element_spacing=\"default\" desktop_text_alignment=\"default\" tablet_text_alignment=\"default\" phone_text_alignment=\"default\" background_color_opacity=\"1\" background_hover_color_opacity=\"1\" column_backdrop_filter=\"none\" column_shadow=\"none\" column_border_radius=\"none\" column_link_target=\"_self\" overflow=\"visible\" gradient_direction=\"left_to_right\" overlay_strength=\"0.3\" width=\"5\/6\" tablet_width_inherit=\"default\" animation_type=\"default\" bg_image_animation=\"none\" border_type=\"simple\" column_border_width=\"none\" column_border_style=\"solid\" column_padding_type=\"default\" gradient_type=\"default\" offset=\"vc_col-xs-10\"]
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\n

Regulatory Affairs<\/span><\/h1>\n <\/div>
<\/div><\/div>[\/vc_column_inner][vc_column_inner column_padding=\"no-extra-padding\" column_padding_tablet=\"inherit\" column_padding_phone=\"inherit\" column_padding_position=\"all\" column_element_direction_desktop=\"default\" column_element_spacing=\"default\" desktop_text_alignment=\"default\" tablet_text_alignment=\"default\" phone_text_alignment=\"default\" background_color_opacity=\"1\" background_hover_color_opacity=\"1\" column_backdrop_filter=\"none\" column_shadow=\"none\" column_border_radius=\"none\" column_link_target=\"_self\" overflow=\"visible\" gradient_direction=\"left_to_right\" overlay_strength=\"0.3\" width=\"1\/6\" tablet_width_inherit=\"default\" animation_type=\"default\" bg_image_animation=\"none\" border_type=\"simple\" column_border_width=\"none\" column_border_style=\"solid\" column_padding_type=\"default\" gradient_type=\"default\" offset=\"vc_col-xs-2\"][vc_custom_heading text=\"07\" font_container=\"tag:h2|font_size:60px|text_align:right|color:%23a72179\" use_theme_fonts=\"yes\" css=\".vc_custom_1702973607449{margin-bottom: 0px !important;}\"][\/vc_column_inner][\/vc_row_inner][vc_row_inner column_margin=\"none\" column_direction=\"default\" column_direction_tablet=\"default\" column_direction_phone=\"default\" bottom_padding=\"30\" text_align=\"left\" row_position=\"default\" row_position_tablet=\"inherit\" row_position_phone=\"inherit\" overflow=\"visible\" pointer_events=\"all\"][vc_column_inner column_padding=\"no-extra-padding\" column_padding_tablet=\"inherit\" column_padding_phone=\"inherit\" column_padding_position=\"all\" column_element_direction_desktop=\"default\" column_element_spacing=\"default\" desktop_text_alignment=\"default\" tablet_text_alignment=\"default\" phone_text_alignment=\"default\" background_color_opacity=\"1\" background_hover_color_opacity=\"1\" column_backdrop_filter=\"none\" column_shadow=\"none\" column_border_radius=\"none\" column_link_target=\"_self\" overflow=\"visible\" gradient_direction=\"left_to_right\" overlay_strength=\"0.3\" width=\"1\/1\" tablet_width_inherit=\"default\" animation_type=\"default\" bg_image_animation=\"none\" border_type=\"simple\" column_border_width=\"none\" column_border_style=\"solid\"][divider line_type=\"Full Width Line\" line_thickness=\"1\" divider_color=\"black\" animate=\"yes\"][divider line_type=\"No Line\" custom_height=\"30\"][nectar_responsive_text max_width=\"780px\"]Support for your research projects throughout the drug life cycle:<\/strong>[\/nectar_responsive_text][nectar_icon_list animate=\"true\" color=\"default\" direction=\"vertical\" icon_size=\"small\" icon_style=\"border\"][nectar_icon_list_item icon_type=\"numerical\" text_full_html=\"html\" title=\"List Item\" id=\"1720073684088-6\" header=\"Types of services we offer during the drug life cycle:<\/strong>\" tab_id=\"1720073684089-9\"]\n
    \n
  • Study start-up:\n
      \n
    • Analysis of requirements and drafting of documents necessary for presentation to the Research Ethics Committee for medicinal products<\/li>\n
    • Protocol design<\/li>\n
    • Submission and presentation<\/li>\n
    • Contract management<\/li>\n
    • Response to ethics committee queries<\/li>\n<\/ul>\n<\/li>\n
    • Monitoring and analysis of study results:\n
        \n
      • Design and Implementation of Electronic CRFs (Case Report Forms)<\/li>\n
      • Monitoring of patient recruitment and resolution of queries<\/li>\n
      • Drafting of interim reports, final report and clinical study report<\/li>\n<\/ul>\n<\/li>\n
      • Positioning of the drug:\n
          \n
        • Value dossiers<\/li>\n
        • Critical analysis of therapeutic positioning report (TPR) and advice on the drafting of allegations<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n[\/nectar_icon_list_item][nectar_icon_list_item icon_type=\"numerical\" text_full_html=\"html\" title=\"List Item\" id=\"1720073684113-6\" header=\"Types of studies on which we work:<\/strong>\" tab_id=\"1720073684113-6\"]\n
            \n
          • Clinical trials<\/li>\n
          • Observational studies<\/li>\n
          • Validation of Medical Devices and Companion Diagnostics<\/li>\n<\/ul>\n[\/nectar_icon_list_item][\/nectar_icon_list][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=\"in_container\" full_screen_row_position=\"middle\" column_margin=\"default\" column_direction=\"default\" column_direction_tablet=\"default\" column_direction_phone=\"default\" scene_position=\"center\" text_color=\"dark\" text_align=\"left\" row_border_radius=\"none\" row_border_radius_applies=\"bg\" overflow=\"visible\" overlay_strength=\"0.3\" gradient_direction=\"left_to_right\" shape_divider_position=\"bottom\" bg_image_animation=\"none\"][vc_column column_padding=\"no-extra-padding\" column_padding_tablet=\"inherit\" column_padding_phone=\"inherit\" column_padding_position=\"all\" column_element_direction_desktop=\"default\" column_element_spacing=\"default\" desktop_text_alignment=\"default\" tablet_text_alignment=\"default\" phone_text_alignment=\"default\" background_color_opacity=\"1\" background_hover_color_opacity=\"1\" column_backdrop_filter=\"none\" column_shadow=\"none\" column_border_radius=\"none\" column_link_target=\"_self\" column_position=\"default\" gradient_direction=\"left_to_right\" overlay_strength=\"0.3\" width=\"1\/1\" tablet_width_inherit=\"default\" animation_type=\"default\" bg_image_animation=\"none\" border_type=\"simple\" column_border_width=\"none\" column_border_style=\"solid\"][nectar_global_section id=\"20831\"][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"

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