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제약

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게시물 Tag: 제약

  • SFDA의 기준 국가는 어디인가요?

    SFDA 참조 국가

  • SFDA에 ICSR 안전 보고서를 제출하는 방법

    SFDA에 개별 사례 안전 보고서(ICSR) 제출

  • 신호 관리 워크숍(2023년 3월 리야드)

  • SFDA에 PSUR을 제출하는 방법과 요구 사항은 무엇입니까?

    SFDA에 대한 정기 안전 업데이트 보고서(PSUR) 제출

  • SFDA에 따른 사우디아라비아의 제품 라벨 및 아트워크 요구 사항.

    SFDA 라벨링 요구 사항(SPC, PIL, IFU, 아트워크)

  • 임상시험 CRO 요구사항

    사우디아라비아 SFDA 임상 시험 요건

  • NDLP: 사우디 제약 시장 규모는 2030년까지 117억 달러로 예상(의료기기 포함)

  • SFDA 수수료 및 신청 및 서비스 비용.

    SFDA 수수료

  • 사우디아라비아의 약물 안전 감시 및 QPPV 요구 사항

  • SFDA-지침의 변형 유형

    SFDA 변경 신청서를 제출하는 방법? (지침 V. 6.3)

  • SFDA-검증-간략-절차

    SFDA 검증 및 약식 약물 절차

  • SFDA-안정성-연구-요건

    SFDA 안정성 연구 요구 사항

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margin_top_medium="0px" spacing="4%" padding_top="0px" padding_right="0px" padding_bottom="0px" padding_left="0px" animation_direction="left" animation_speed="0.3" animation_offset="top-into-view" target="_self" hover_type="none" center_content="no" filter_hue="0" filter_saturation="100" filter_brightness="100" filter_contrast="100" filter_invert="0" filter_sepia="0" filter_opacity="100" filter_blur="0" filter_hue_hover="0" filter_saturation_hover="100" filter_brightness_hover="100" filter_contrast_hover="100" filter_invert_hover="0" filter_sepia_hover="0" filter_opacity_hover="100" filter_blur_hover="0" align_self="stretch" order_medium="9" order_small="4" align_content="center" valign_content="flex-start" content_wrap="wrap" content_layout="column" last="true" background_type="single" filter_type="regular" first="false" spacing_left="1%" spacing_left_small="2%" spacing_right_small="0%"][fusion_menu active_border_color="var(--awb-color6)" active_border_bottom="2px" active_border_left="0px" active_border_right="0px" active_border_top="0px" active_color="var(--awb-color6)" align_items="center" animation_direction="left" animation_offset="top-into-view" animation_speed="0.3" arrows_size_height="12px" arrows_size_width="23px" border_bottom="2px" border_right="0px" border_top="0px" border_left="0px" border_radius_bottom_left="0px" border_radius_bottom_right="0px" border_radius_top_left="0px" border_radius_top_right="0px" box_shadow="yes" box_shadow_blur="26" box_shadow_color="var(--awb-color5)" box_shadow_horizontal="10px" box_shadow_spread="-10" box_shadow_vertical="10px" breakpoint="never" custom_breakpoint="800" collapsed_mode="dropdown" collapsed_nav_icon_close="fa-times fas" collapsed_nav_icon_open="fa-bars fas" color="var(--awb-color8)" direction="row" dropdown_carets="yes" expand_direction="right" expand_method="hover" submenu_mode="dropdown" submenu_flyout_direction="fade" expand_transition="fade" font_size="14px" fusion_font_family_mobile_typography="var(--awb-typography3-font-family)" fusion_font_family_submenu_typography="var(--awb-typography3-font-family)" fusion_font_family_typography="var(--awb-typography5-font-family)" fusion_font_variant_mobile_typography="var(--awb-typography3)" fusion_font_variant_submenu_typography="var(--awb-typography3)" fusion_font_variant_typography="var(--awb-typography5)" gap="28px" hide_on_mobile="small-visibility,medium-visibility,large-visibility" icons_color="var(--awb-color8)" icons_hover_color="var(--awb-color6)" icons_position="left" icons_size="14" items_padding_bottom="0px" items_padding_left="0px" items_padding_right="0px" items_padding_top="0px" justify_content="flex-start" justify_title="flex-start" margin_bottom="0px" margin_top="0px" menu="footer-terms-privacy" min_height="36px" mobile_font_size="var(--awb-typography3-font-size)" mobile_trigger_font_size="1em" mobile_indent_submenu="on" mobile_nav_button_align_hor="flex-start" mobile_nav_items_height="65" mobile_nav_mode="collapse-to-button" mobile_nav_size="full-absolute" mobile_nav_trigger_fullwidth="off" mobile_nav_trigger_bottom_margin="0px" mobile_trigger_color="var(--awb-color8)" sticky_display="normal,sticky" submenu_active_bg="var(--awb-color3)" submenu_active_color="var(--awb-color6)" submenu_border_radius_bottom_left="12px" submenu_border_radius_bottom_right="12px" submenu_border_radius_top_left="12px" submenu_border_radius_top_right="12px" submenu_color="var(--awb-color8)" submenu_font_size="var(--awb-typography3-font-size)" submenu_items_padding_bottom="14px" submenu_items_padding_left="26px" submenu_items_padding_right="26px" submenu_items_padding_top="14px" submenu_sep_color="hsla(var(--awb-color3-h),var(--awb-color3-s),var(--awb-color3-l),calc(var(--awb-color3-a) - 100%))" submenu_space="8px" submenu_text_transform="var(--awb-typography3-text-transform)" text_transform="var(--awb-typography5-text-transform)" thumbnail_size_height="14px" thumbnail_size_width="26px" transition_time="300" transition_type="left" trigger_padding_bottom="12px" trigger_padding_left="20px" trigger_padding_right="20px" trigger_padding_top="12px" mobile_justify_content="left" main_justify_content="left" line_height="var(--awb-typography5-line-height)" letter_spacing="var(--awb-typography5-letter-spacing)" mobile_line_height="var(--awb-typography3-line-height)" mobile_letter_spacing="var(--awb-typography3-letter-spacing)" mobile_text_transform="var(--awb-typography3-text-transform)" submenu_line_height="var(--awb-typography3-line-height)" submenu_letter_spacing="var(--awb-typography3-letter-spacing)" /][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]
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  • 집
  • 서비스
    • 규제 업무 서비스
    • Pharmacovigilance 서비스
    • 고품질 서비스
  • 에 대한
  • 통찰력
  • 문의하기
  • 한국어
    • English
    • عربي
    • Deutsch
    • 简体中文
    • Français
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당사 비즈니스 지원팀에 문의하세요

일요일 ~ 목요일: 오전 9시 ~ 오후 5시

+966 11 277 7729

+966 11 240 4409

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