{"id":49623,"date":"2022-05-11T08:07:02","date_gmt":"2022-05-11T06:07:02","guid":{"rendered":"https:\/\/www.pharma-service.cz\/?page_id=49623"},"modified":"2024-04-10T12:27:13","modified_gmt":"2024-04-10T10:27:13","slug":"services","status":"publish","type":"page","link":"https:\/\/www.pharma-service.cz\/cs\/services\/","title":{"rendered":"Slu\u017eby"},"content":{"rendered":"

[et_pb_section fb_built=”1″ admin_label=”Sekce” _builder_version=”4.21.0″ background_color=”rgba(255,255,255,0.78)” background_image=”https:\/\/www.pharma-service.cz\/wp-content\/uploads\/2023\/04\/pozadi_molekuly-scaled.jpg” background_size=”contain” background_repeat=”repeat” background_blend=”color” custom_margin=”||||false|false” custom_margin_tablet=”95px||||false|false” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”|0px|80px|0px|false|false” da_disable_devices=”off|off|off” global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row admin_label=”\u0158\u00e1dek” _builder_version=”4.21.0″ custom_padding=”75px|0px|65px|0px|false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.24.3″ text_font=”|700|||||||” text_text_color=”#000000″ text_font_size=”30px” text_orientation=”center” custom_padding=”||||false|false” text_font_size_tablet=”” text_font_size_phone=”20px” text_font_size_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n

Our Services<\/h1>\n

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With focus on the unique needs of each client we are helping, offering and providing pharmacovigilance and regulatory services throughout all phases of the product lifecycle to deliver quality, safe and efficient products on the European market. We are ready to represent you in the following areas:<\/p>\n

[\/et_pb_text][et_pb_divider divider_position=”bottom” divider_weight=”1.5px” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_5,1_5,1_5,1_5,1_5″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” custom_padding_last_edited=”on|phone” disabled_on=”on|on|on” admin_label=”\u0158\u00e1dek” _builder_version=”4.21.0″ width=”90%” max_width=”1280px” custom_margin_tablet=”” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”||65px|||” custom_padding_tablet=”||65px|||” custom_padding_phone=”0px||65px||false|false” disabled=”on” global_colors_info=”{}”][et_pb_column type=”1_5″ admin_label=”Sloupec” _builder_version=”4.19.0″ background_color=”#0C5757″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||” background_color__hover=”#0C5757″ background__hover_enabled=”on|hover” background_enable_color__hover=”on”][et_pb_cta title=”PHARMACOVIGILANCE” button_url=”https:\/\/www.pharma-service.cz\/services\/#phv” button_text=”VIEW MORE” _builder_version=”4.21.0″ header_font=”Poppins|600||on|||||” header_text_color=”#FFFFFF” header_font_size=”18px” header_line_height=”1.5em” body_font=”Roboto|300|||||||” body_text_color=”#FFFFFF” body_font_size=”15px” body_line_height=”1.8em” background_color=”RGBA(255,255,255,0)” custom_button=”on” button_text_size=”14px” button_text_color=”#FFFFFF” button_bg_color=”rgba(56,56,56,0)” button_border_width=”0px” button_border_color=”#383838″ button_border_radius=”0px” button_letter_spacing=”1px” button_font=”Poppins|||on|||||” button_icon=”$||divi||400″ button_on_hover=”off” button_alignment=”center” custom_padding=”50px|10px|50px|10px|true|false” border_color_all=”#c4c4c4″ button_text_color_hover=”#3FA2F7 ” button_border_color_hover=”rgba(0,0,0,0)” button_letter_spacing_hover=”3px” button_bg_color_hover=”rgba(0,0,0,0)” global_colors_info=”{}” button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”on|hover” button_text_color__hover=”#F5F5F5″ button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”on” button_border_color__hover=”rgba(191,191,191,0)” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”on” button_letter_spacing__hover=”2px” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”on” button_bg_color__hover=”rgba(191,191,191,0)” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off” background_color__hover=”#0C5757″ background_enable_color__hover=”on” background__hover_enabled=”on|hover”]<\/p>\n

EU QPPV
Local PV Contact
SAE\/SUSAR Reporting
Literature Monitoring
Trainings<\/p>\n

[\/et_pb_cta][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.19.0″ background_color=”#0C5757″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||” background_color__hover=”#0C5757″ background_enable_color__hover=”on” background__hover_enabled=”on|hover”][et_pb_cta title=”REGULATORY AFFAIRS” button_url=”https:\/\/www.pharma-service.cz\/services\/#ra” button_text=”VIEW MORE” _builder_version=”4.19.0″ header_font=”Poppins|600||on|||||” header_text_color=”#FFFFFF” header_font_size=”18px” header_line_height=”1.5em” body_font=”Roboto|300|||||||” body_text_color=”#FFFFFF” body_font_size=”15px” body_line_height=”1.8em” background_color=”RGBA(255,255,255,0)” custom_button=”on” button_text_size=”14px” button_text_color=”#FFFFFF” button_bg_color=”rgba(56,56,56,0)” button_border_width=”0px” button_border_color=”#383838″ button_border_radius=”0px” button_letter_spacing=”1px” button_font=”Poppins|||on|||||” button_icon=”$||divi||400″ button_on_hover=”off” button_alignment=”center” custom_padding=”50px|10px|50px|10px|true|false” border_color_all=”#c4c4c4″ button_text_color_hover=”#3FA2F7 ” button_border_color_hover=”rgba(0,0,0,0)” button_letter_spacing_hover=”3px” button_bg_color_hover=”rgba(0,0,0,0)” global_colors_info=”{}” button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”on|hover” button_text_color__hover=”#F5F5F5″ button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”on” button_border_color__hover=”rgba(191,191,191,0)” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”on” button_letter_spacing__hover=”2px” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”on” button_bg_color__hover=”rgba(191,191,191,0)” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off” background_color__hover=”#0C5757″ background_enable_color__hover=”on” background__hover_enabled=”on|hover”]<\/p>\n

Regulatory Strategy
Dossier Audits
Artwork\/Labelling
eCTD Publishing
Regulatory Intelligence<\/p>\n

[\/et_pb_cta][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.19.0″ background_color=”#0C5757″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||” background_color__hover=”#0C5757″ background__hover_enabled=”on|hover” background_enable_color__hover=”on”][et_pb_cta title=”GxP COMPLIANCE” button_url=”https:\/\/www.pharma-service.cz\/services\/#qa” button_text=”VIEW MORE” _builder_version=”4.19.0″ header_font=”Poppins|600||on|||||” header_text_color=”#FFFFFF” header_font_size=”18px” header_line_height=”1.5em” body_font=”Roboto|300|||||||” body_text_color=”#FFFFFF” body_font_size=”15px” body_line_height=”1.8em” background_color=”RGBA(255,255,255,0)” custom_button=”on” button_text_size=”14px” button_text_color=”#FFFFFF” button_bg_color=”rgba(56,56,56,0)” button_border_width=”0px” button_border_color=”#383838″ button_border_radius=”0px” button_letter_spacing=”1px” button_font=”Poppins|||on|||||” button_icon=”$||divi||400″ button_on_hover=”off” button_alignment=”center” custom_padding=”50px|10px|50px|10px|true|false” border_color_all=”#c4c4c4″ button_text_color_hover=”#3FA2F7 ” button_border_color_hover=”rgba(0,0,0,0)” button_letter_spacing_hover=”3px” button_bg_color_hover=”rgba(0,0,0,0)” global_colors_info=”{}” button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”on|hover” button_text_color__hover=”#F5F5F5″ button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”on” button_border_color__hover=”rgba(191,191,191,0)” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”on” button_letter_spacing__hover=”2px” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”on” button_bg_color__hover=”rgba(191,191,191,0)” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off” background_color__hover=”#0C5757″ background_enable_color__hover=”on” background__hover_enabled=”on|hover”]<\/p>\n

Auditing
Quality System Management
Gap Analysis
Trainings
GDP Services<\/p>\n

[\/et_pb_cta][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.19.0″ background_color=”#0C5757″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||” background_color__hover=”#0C5757″ background__hover_enabled=”on|hover” background_enable_color__hover=”on”][et_pb_cta title=”Medical writing” button_url=”https:\/\/www.pharma-service.cz\/services\/#mw” button_text=”VIEW MORE” _builder_version=”4.21.0″ header_font=”Poppins|600||on|||||” header_text_color=”#FFFFFF” header_font_size=”18px” header_line_height=”1.5em” body_font=”Roboto|300|||||||” body_text_color=”#FFFFFF” body_font_size=”15px” body_line_height=”1.8em” background_color=”RGBA(255,255,255,0)” custom_button=”on” button_text_size=”14px” button_text_color=”#FFFFFF” button_bg_color=”rgba(56,56,56,0)” button_border_width=”0px” button_border_color=”#383838″ button_border_radius=”0px” button_letter_spacing=”1px” button_font=”Poppins|||on|||||” button_icon=”$||divi||400″ button_on_hover=”off” button_alignment=”center” custom_padding=”50px|10px|50px|10px|true|false” border_color_all=”#c4c4c4″ button_text_color_hover=”#3FA2F7 ” button_border_color_hover=”rgba(0,0,0,0)” button_letter_spacing_hover=”3px” button_bg_color_hover=”rgba(0,0,0,0)” global_colors_info=”{}” button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”on|hover” button_text_color__hover=”#F5F5F5″ button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”on” button_border_color__hover=”rgba(191,191,191,0)” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”on” button_letter_spacing__hover=”2px” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”on” button_bg_color__hover=”rgba(191,191,191,0)” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off” background_color__hover=”#0C5757″ background_enable_color__hover=”on” background__hover_enabled=”on|hover”]<\/p>\n

Risk Management Plan
PSUR
Clinical Overview
Preclinical Overview
Other Medical Support<\/p>\n

[\/et_pb_cta][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.19.0″ background_color=”#0C5757″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||” background_color__hover=”#0C5757″ background__hover_enabled=”on|hover” background_enable_color__hover=”on”][et_pb_cta title=”Other” button_url=”https:\/\/www.pharma-service.cz\/services\/#other” button_text=”VIEW MORE” _builder_version=”4.21.0″ header_font=”Poppins|600||on|||||” header_text_color=”#FFFFFF” header_font_size=”18px” header_line_height=”1.5em” body_font=”Roboto|300|||||||” body_text_color=”#FFFFFF” body_font_size=”15px” body_line_height=”1.8em” background_color=”RGBA(255,255,255,0)” custom_button=”on” button_text_size=”14px” button_text_color=”#FFFFFF” button_bg_color=”rgba(56,56,56,0)” button_border_width=”0px” button_border_color=”#383838″ button_border_radius=”0px” button_letter_spacing=”1px” button_font=”Poppins|||on|||||” button_icon=”$||divi||400″ button_on_hover=”off” button_alignment=”center” custom_padding=”50px|10px|50px|10px|true|false” border_color_all=”#c4c4c4″ button_text_color_hover=”#3FA2F7 ” button_border_color_hover=”rgba(0,0,0,0)” button_letter_spacing_hover=”3px” button_bg_color_hover=”rgba(0,0,0,0)” global_colors_info=”{}” button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”on|hover” button_text_color__hover=”#F5F5F5″ button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”on” button_border_color__hover=”rgba(191,191,191,0)” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”on” button_letter_spacing__hover=”2px” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”on” button_bg_color__hover=”rgba(191,191,191,0)” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off” background_color__hover=”#0C5757″ background_enable_color__hover=”on” background__hover_enabled=”on|desktop”]Medical devices
\nFood supplements
\nCosmetics
\nProduct status
\n [\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row use_custom_gutter=”on” gutter_width=”4″ make_equal=”on” admin_label=”\u0158\u00e1dek” module_id=”phv” _builder_version=”4.21.0″ width_tablet=”90%” width_phone=”90%” width_last_edited=”off|phone” max_width_tablet=”90%” max_width_phone=”90%” max_width_last_edited=”off|tablet” custom_margin=”60px|auto||auto|false|false” custom_margin_tablet=”80px|auto||auto||” custom_margin_phone=”30px|auto||auto|false|false” custom_margin_last_edited=”on|phone” custom_padding=”|0px||0px|false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.24.3″ text_font=”|700|||||||” text_text_color=”#000000″ text_font_size=”30px” text_orientation=”center” custom_padding=”||||false|false” text_font_size_tablet=”30px” text_font_size_phone=”20px” text_font_size_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n

Pharmacovigilance<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.24.3″ text_font=”|300|||||||” text_text_color=”#000000″ text_font_size=”15px” text_line_height=”1.8em” text_orientation=”center” width=”70%” max_width=”1920px” max_width_tablet=”80%” max_width_phone=”90%” max_width_last_edited=”on|desktop” module_alignment=”center” custom_margin=”||||false|false” custom_padding=”0px||” global_colors_info=”{}”]<\/p>\n

We will be your trustable partner to ensure quality and safety products on the market. We are able to provide you with unique support and services tailored especially to your product portfolio and project needs.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.21.0″ _module_preset=”default” background_color=”rgba(255,255,255,0)” width=”100%” custom_margin=”|auto|40px|auto|false|false” custom_padding=”|30px|30px|30px|false|true” border_radii=”off||||” global_colors_info=”{}”][et_pb_column type=”4_4″ admin_label=”Sloupec” _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipl_image_card_carousel equalize_slides_height=”on” autoplay=”off” show_arrow=”on” arrows_position=”outside” show_control_dot=”on” control_dot_style=”line” arrows_custom_padding=”5px|0px|5px|0px|true|true” arrow_font_size=”35px” arrow_color=”#FFFFFF” control_dot_active_color=”#0A7E8C” control_dot_inactive_color=”#F5F5F5″ icon_color=”#0A7E8C” slider_container_custom_padding=”|20px||20px|false|true” cards_per_slide_tablet=”2″ cards_per_slide_phone=”1″ cards_per_slide_last_edited=”on|phone” _builder_version=”4.24.3″ _module_preset=”default” title_font=”|600|||||||” background_color=”rgba(70,179,159,0.61)” text_orientation=”center” custom_margin=”||||false|true” custom_padding=”45px|40px||40px|false|true” global_colors_info=”{}”][dipl_image_card_carousel_item title=”EU QPPV\/Local PV Contact” icon=”||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.23.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We act as your European or Local contact person for monitoring of drug safety on the market in the Czech Republic and other selected EU countries.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Pharmacovigilance system” icon=”||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We help you to establish the full pharmacovigilance system (PSMF), including appropriate SOPs<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Reporting” icon=”l||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

Entrust us with your responsibility to appropriately report adverse events and reactions accordingly.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Monitoring” icon=”U||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.23.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We monitor literature journals on regular basis to fulfill obligations. To ensure up-to date status of all processes we also check respective news in pharmacovigilance area.<\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Training” icon=”||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We are ready to train you on the pharmacovigilance basis and provide you annual training for all your employees.<\/p>\n

[\/dipl_image_card_carousel_item][\/dipl_image_card_carousel][\/et_pb_column][\/et_pb_row][et_pb_row module_id=”ra” _builder_version=”4.21.0″ custom_margin=”||||false|false” custom_padding=”|0px||0px|false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.24.3″ text_font=”|700|||||||” text_text_color=”#000000″ text_font_size=”30px” text_orientation=”center” custom_padding=”||||false|false” text_font_size_tablet=”” text_font_size_phone=”20px” text_font_size_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n

Regulatory affairs<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.24.3″ text_font=”|300|||||||” text_text_color=”#000000″ text_font_size=”15px” text_line_height=”1.8em” text_orientation=”center” width=”70%” max_width=”1920px” max_width_tablet=”80%” max_width_phone=”90%” max_width_last_edited=”on|desktop” module_alignment=”center” custom_margin=”||||false|false” custom_padding=”0px||” global_colors_info=”{}”]<\/p>\n

Full expertise in regulatory affairs allows us to reach your goals in all stages from pharmaceutical development to medical product launch and help you to continue smoothly throughout the maintenance phase of the product lifecycle.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.21.0″ _module_preset=”default” background_color=”rgba(255,255,255,0)” width=”100%” custom_margin=”|auto|40px|auto|false|false” custom_padding=”|30px|30px|30px|false|true” border_radii=”off||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipl_image_card_carousel equalize_slides_height=”on” autoplay=”off” show_arrow=”on” arrows_position=”outside” show_control_dot=”on” control_dot_style=”line” arrows_custom_padding=”5px|0px|5px|0px|true|true” arrow_font_size=”35px” arrow_color=”#FFFFFF” control_dot_active_color=”#0A7E8C” control_dot_inactive_color=”#F5F5F5″ icon_color=”#0A7E8C” slider_container_custom_padding=”|20px||20px|false|true” cards_per_slide_tablet=”2″ cards_per_slide_phone=”1″ cards_per_slide_last_edited=”on|phone” _builder_version=”4.24.3″ _module_preset=”default” title_font=”|600|||||||” background_color=”rgba(70,179,159,0.61)” text_orientation=”center” custom_margin=”||||false|true” custom_padding=”45px|40px||40px|false|true” global_colors_info=”{}”][dipl_image_card_carousel_item title=”Dossier audit or gap analysis” icon=”||fa||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

Submission of the suitable dossier can avoid future deficiencies raised by the authorities during the procedure. That is why resolving technical discrepancies prior to the submission save time and cost delays.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Regulatory strategy” icon=”l||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We create, discuss or implement your regulatory strategy to ensure a product launch in timely manner, following necessary guidelines and considering relevant costs.<\/p>\n

\u200b<\/span><\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Dossier compilation” icon=”i||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We collaborate with your manufacturing site(s) and other experts to ensure the presented dossier <\/span>\u200bis suitable for the submission containing relevant parts of Module 1-5.<\/span><\/p>\n

\u200b<\/span><\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”eCTD publishing” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We assembly and complete regulatory dossier that enables you to handle electronic submissions, build, view, validate and publish required submission format of eCTD and keep track of all changes and updates to life cycle documentation<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Dossier submission” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We ensure dossier delivery by the relevant portal (CESP) or personally to the agency, giving you feedback and collaborate on any validation issues raised by the authority.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Authority follow-up” icon=”||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We monitor the progress of the submission with relevant authorities, keeping you fully informed about any deficiencies addressed with regards to your procedure.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Life-cycle management” icon=”||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We ensure the dossier compliance by submission of relevant variations, renewals to the authority to keep the documentation up to date.<\/p>\n

\u200b<\/span><\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Communication with Authority” icon=”w||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.23.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We act as your local contact person in the Czech Republic and other countries in EU. Or communicate within EU on behalf of an applicant. <\/span><\/p>\n

<\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Marketing advertising approval” icon=”N||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We assess and approve your promotional materials in accordance with the latest approved package information, considering the regulation of marketing claims.\u00a0<\/span><\/p>\n

[\/dipl_image_card_carousel_item][\/dipl_image_card_carousel][\/et_pb_column][\/et_pb_row][et_pb_row module_id=”qa” _builder_version=”4.21.0″ custom_padding=”|0px||0px|false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.24.3″ text_font=”|700|||||||” text_text_color=”#000000″ text_font_size=”30px” text_orientation=”center” custom_padding=”||||false|false” text_font_size_tablet=”” text_font_size_phone=”20px” text_font_size_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n

GxP Compliance<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.24.3″ text_font=”|300|||||||” text_text_color=”#000000″ text_font_size=”15px” text_line_height=”1.8em” text_orientation=”center” width=”70%” max_width=”1920px” max_width_tablet=”80%” max_width_phone=”90%” max_width_last_edited=”on|desktop” module_alignment=”center” custom_margin=”||||false|false” custom_padding=”0px||” global_colors_info=”{}”]<\/p>\n

We are here to support you in case of compliance improvement needs, to establish tailored made quality system manual and maintenance the quality by regular audits.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.21.0″ _module_preset=”default” background_color=”rgba(255,255,255,0)” width=”100%” custom_margin=”|auto|40px|auto|false|false” custom_padding=”|30px|30px|30px|false|true” border_radii=”off||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipl_image_card_carousel equalize_slides_height=”on” autoplay=”off” show_arrow=”on” arrows_position=”outside” show_control_dot=”on” control_dot_style=”line” arrows_custom_padding=”5px|0px|5px|0px|true|true” arrow_font_size=”35px” arrow_color=”#FFFFFF” control_dot_active_color=”#0A7E8C” control_dot_inactive_color=”#F5F5F5″ icon_color=”#0A7E8C” slider_container_custom_padding=”|20px||20px|false|true” cards_per_slide_tablet=”2″ cards_per_slide_phone=”1″ cards_per_slide_last_edited=”on|phone” _builder_version=”4.24.3″ _module_preset=”default” title_font=”|600|||||||” background_color=”rgba(70,179,159,0.61)” text_orientation=”center” custom_margin=”||||false|true” custom_padding=”45px|40px||40px|false|true” global_colors_info=”{}”][dipl_image_card_carousel_item title=”Auditing” icon=”||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We perfom internal audits of the documentation (Company policies, Standard operating procedures, Working Instructions…etc.) with the aim to verify established processes.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Quality System Management” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We help companies to establish an efficient quality management system (QMS). Propose and prepare a robust system of SOPs in accordance with the latest requirements.<\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Qualified person” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We are qualified for the role of Qualified Person (QP) as per Directive 2001\/83\/EC and take responsibility to release a batch to the distribution.<\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Gap Analysis” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We help you to identify potential deficiencies in processes and prepare corrective measures and analysis for improvement.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Trainings” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We are ready to provide specific training to cover your need and prepare annual trainings for your employees.<\/p>\n

[\/dipl_image_card_carousel_item][\/dipl_image_card_carousel][\/et_pb_column][\/et_pb_row][et_pb_row module_id=”mw” _builder_version=”4.21.0″ custom_padding=”|0px||0px|false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.24.3″ text_font=”|700|||||||” text_text_color=”#000000″ text_font_size=”30px” text_orientation=”center” custom_padding=”||||false|false” text_font_size_tablet=”” text_font_size_phone=”20px” text_font_size_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n

Medical writting<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.21.0″ _module_preset=”default” background_color=”rgba(255,255,255,0)” width=”100%” custom_margin=”|auto|40px|auto|false|false” custom_padding=”|30px|30px|30px|false|true” border_radii=”off||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipl_image_card_carousel equalize_slides_height=”on” autoplay=”off” show_arrow=”on” arrows_position=”outside” show_control_dot=”on” control_dot_style=”line” arrows_custom_padding=”5px|0px|5px|0px|true|true” arrow_font_size=”35px” arrow_color=”#FFFFFF” control_dot_active_color=”#0A7E8C” control_dot_inactive_color=”#F5F5F5″ icon_color=”#0A7E8C” slider_container_custom_padding=”|20px||20px|false|true” cards_per_slide_tablet=”2″ cards_per_slide_phone=”1″ cards_per_slide_last_edited=”on|phone” _builder_version=”4.24.3″ _module_preset=”default” title_font=”|600|||||||” background_color=”rgba(70,179,159,0.61)” text_orientation=”center” custom_margin=”||||false|true” custom_padding=”45px|40px||40px|false|true” global_colors_info=”{}”][dipl_image_card_carousel_item title=”Risk Management Plan” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_enable_color=”on” global_colors_info=”{}”]<\/p>\n

We are experienced in medical writing of Risk Management Plans (RMPs) to cover safety development of the product.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”PSUR” icon=”||divi||400″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_enable_color=”on” global_colors_info=”{}”]<\/p>\n

We will prepare for you PSURs, the accumulated information on a given product and present it in a systematic order to check-up on a drug\u2019s or substance\u2019s safety.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Clinical Overview” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_enable_color=”on” global_colors_info=”{}”]<\/p>\n

We write the Clinical Overview (CO) a vital part of the Common Technical Document (CTD), that describe critical, appropriately supportive assessment of the data that has to justify the proposed Summary of Product Characteristics (SmPC).<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Pre-clinical Overview” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_enable_color=”on” global_colors_info=”{}”]<\/p>\n

We prepare the preclinical evaluations that are the key component of drug development. Non-clinical report is in comprise a comprehensive scientific programme that spans the whole lifecycle of the compound.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Other Medical Support ” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.21.0″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_enable_color=”on” global_colors_info=”{}”]<\/p>\n

We support you in case of any other need to write specific regulatory document related to clinical evaluation, similarity of medicinal products, addendums for renewals or clinical summaries.<\/p>\n

[\/dipl_image_card_carousel_item][\/dipl_image_card_carousel][\/et_pb_column][\/et_pb_row][et_pb_row module_id=”other” _builder_version=”4.21.0″ custom_padding=”|0px||0px|false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.24.3″ text_font=”|700|||||||” text_text_color=”#000000″ text_font_size=”30px” text_orientation=”center” custom_padding=”||||false|false” text_font_size_tablet=”” text_font_size_phone=”20px” text_font_size_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n

Other<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.21.0″ _module_preset=”default” background_color=”rgba(255,255,255,0)” width=”100%” custom_margin=”|auto||auto|false|false” custom_padding=”|30px|30px|30px|false|true” border_radii=”off||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.19.0″ _module_preset=”default” global_colors_info=”{}”][dipl_image_card_carousel equalize_slides_height=”on” autoplay=”off” show_arrow=”on” arrows_position=”outside” show_control_dot=”on” control_dot_style=”line” arrows_custom_padding=”5px|0px|5px|0px|true|true” arrow_font_size=”35px” arrow_color=”#FFFFFF” control_dot_active_color=”#0A7E8C” control_dot_inactive_color=”#F5F5F5″ icon_color=”#0A7E8C” slider_container_custom_padding=”|20px||20px|false|true” cards_per_slide_tablet=”2″ cards_per_slide_phone=”1″ cards_per_slide_last_edited=”on|phone” _builder_version=”4.24.3″ _module_preset=”default” title_font=”|600|||||||” background_color=”rgba(70,179,159,0.61)” text_orientation=”center” custom_margin=”||||false|true” custom_padding=”45px|40px||40px|false|true” global_colors_info=”{}”][dipl_image_card_carousel_item title=”Preparation of instructions for use” icon=”||fa||400″ content_bg_color=”#FFFFFF” _builder_version=”4.23.4″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_enable_color=”on” global_colors_info=”{}”]<\/p>\n

We check or prepare instructions for use in the Czech\/Slovak <\/span>language laying emphasis on its essential contents for the purpose of the product notification.<\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Notification with CPNP” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.23.4″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_enable_color=”on” global_colors_info=”{}”]<\/p>\n

We support companies who intents or supply cosmetics on the market in the Czech\/Slovak <\/span>Republic to submit an application for notification of their products. And we also communicate with Authority on their behalf with the aim to get an approval letter.<\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Notification with Registry of Medical Devices” icon=”||fa||900″ icon_color=”#0A7E8C” content_bg_color=”#FFFFFF” _builder_version=”4.23.4″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_enable_color=”on” global_colors_info=”{}”]<\/p>\n

We support companies who intent or supply medical devices on the market in the Czech\/Slovak <\/span>Republic to fully comply with the new MDR legislation. their behalf with the aim to get an approval letter.<\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Marketability” icon=”||fa||900″ content_bg_color=”#FFFFFF” _builder_version=”4.23.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We give you our expertise on the acceptable product status in the Czech\/Slovak <\/span>Republic based on the product composition and intended use. We also communicate the issues with relevant authorities.\u00a0<\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Notification with Authority” icon=”||fa||900″ content_bg_color=”#FFFFFF” _builder_version=”4.23.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We ensure the product notification with the relevant authority in order to be marketable in the Czech\/Slovak <\/span>Republic.<\/span><\/p>\n

[\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Labelling & health claims ” icon=”||fa||900″ content_bg_color=”#FFFFFF” _builder_version=”4.23.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We prepare, assess or correct your labelling in accordance with EU regulation also incorporating additional parts as per Czech\/Slovak <\/span>requirements.\u00a0<\/span><\/p>\n

[\/dipl_image_card_carousel_item][\/dipl_image_card_carousel][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Sekce” _builder_version=”4.21.0″ _module_preset=”default” background_color=”#0c5757″ width=”100%” max_width=”100%” custom_margin=”0px|0px|0px|0px|true|false” custom_padding=”0px|0px|0px|0px|true|false” da_disable_devices=”off|off|off” global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” gutter_width=”1″ make_equal=”on” _builder_version=”4.21.0″ _module_preset=”default” width=”100%” max_width=”2560px” module_alignment=”center” custom_margin=”0px||0px||true|false” custom_padding=”0px||0px||true|false” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.pharma-service.cz\/wp-content\/uploads\/2023\/05\/RA-scaled.jpg” title_text=”RA” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.pharma-service.cz\/wp-content\/uploads\/2023\/05\/Spol-scaled.jpg” title_text=”Spol” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.pharma-service.cz\/wp-content\/uploads\/2023\/05\/PV-scaled.jpg” title_text=”PV” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

Our ServicesWith focus on the unique needs of each client we are helping, offering and providing pharmacovigilance and regulatory services throughout all phases of the product lifecycle to deliver quality, safe and efficient products on the European market. We are ready to represent you in the following areas:EU QPPVLocal PV ContactSAE\/SUSAR ReportingLiterature MonitoringTrainingsRegulatory StrategyDossier AuditsArtwork\/LabellingeCTD […]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-49623","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.pharma-service.cz\/cs\/wp-json\/wp\/v2\/pages\/49623","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharma-service.cz\/cs\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.pharma-service.cz\/cs\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharma-service.cz\/cs\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharma-service.cz\/cs\/wp-json\/wp\/v2\/comments?post=49623"}],"version-history":[{"count":173,"href":"https:\/\/www.pharma-service.cz\/cs\/wp-json\/wp\/v2\/pages\/49623\/revisions"}],"predecessor-version":[{"id":50805,"href":"https:\/\/www.pharma-service.cz\/cs\/wp-json\/wp\/v2\/pages\/49623\/revisions\/50805"}],"wp:attachment":[{"href":"https:\/\/www.pharma-service.cz\/cs\/wp-json\/wp\/v2\/media?parent=49623"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}