{"id":393409,"date":"2022-12-12T15:42:40","date_gmt":"2022-12-12T15:42:40","guid":{"rendered":"https:\/\/xtrategicalpharma.com\/home\/"},"modified":"2025-06-30T11:28:25","modified_gmt":"2025-06-30T11:28:25","slug":"home","status":"publish","type":"page","link":"https:\/\/xtrategicalpharma.com\/en\/","title":{"rendered":"Home"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.26.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;RGBA(255,255,255,0)&#8221; background_enable_image=&#8221;off&#8221; vertical_offset_tablet=&#8221;0&#8243; horizontal_offset_tablet=&#8221;0&#8243; custom_margin=&#8221;0px||0px||false|false&#8221; custom_margin_tablet=&#8221;0px||0px||false|false&#8221; custom_margin_phone=&#8221;-71px||-30px||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;0px||0px|||&#8221; animation_style=&#8221;fade&#8221; background_last_edited=&#8221;on|phone&#8221; use_background_color_gradient_phone=&#8221;on&#8221; 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In each project, we do our best to add value, in the sense of not being just a service provider, but your partner of choice, enabling you to anticipate and overcome challenges for a successful collaboration. 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header_line_height_last_edited=&#8221;on|phone&#8221; header_2_font_size_tablet=&#8221;57px&#8221; header_2_font_size_phone=&#8221;30px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; header_2_line_height_tablet=&#8221;&#8221; header_2_line_height_phone=&#8221;1.4em&#8221; header_2_line_height_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>ServiCES<\/h2>\n<p>[\/et_pb_text][et_pb_divider color=&#8221;#C61FE0&#8243; divider_weight=&#8221;4px&#8221; _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;8%&#8221; module_alignment=&#8221;center&#8221; global_colors_info=&#8221;{}&#8221;]<br \/>\n[\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; make_equal=&#8221;on&#8221; disabled_on=&#8221;off|off|on&#8221; _builder_version=&#8221;4.24.3&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#FFFFFF&#8221; width_tablet=&#8221;&#8221; width_phone=&#8221;100%&#8221; width_last_edited=&#8221;on|phone&#8221; module_alignment=&#8221;center&#8221; custom_padding=&#8221;0px|30px|0px|30px|false|true&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.3&#8243; _module_preset=&#8221;default&#8221; background_image=&#8221;https:\/\/xtrategicalpharma.com\/wp-content\/uploads\/2024\/04\/shutterstock_2250826119.jpg&#8221; custom_padding=&#8221;300px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider show_divider=&#8221;off&#8221; _builder_version=&#8221;4.24.3&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<br \/>\n[\/et_pb_divider][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;80px||80px||true|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text content_tablet=&#8221;<\/p>\n<h2><strong>Marca\u00e7\u00e3o CE e Documenta\u00e7\u00e3o para Dispositivos M\u00e9dicos<\/strong><\/h2>\n<p>&#8221; content_phone=&#8221;<\/p>\n<h2 style=%22text-align: center;%22>REGULATORY AFFAIRS<\/h2>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#416AA4&#8243; header_text_color=&#8221;#416AA4&#8243; header_2_font=&#8221;Poppins|||on|||||&#8221; header_2_text_color=&#8221;#416AA4&#8243; header_2_line_height=&#8221;1.7em&#8221; custom_margin=&#8221;-65px||20px|||&#8221; hover_enabled=&#8221;0&#8243; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;18px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2 style=\"text-align: center;\">REGULATORY AFFAIRS<\/h2>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<p>Criar um Sistema de Gest\u00e3o de Qualidade e Documenta\u00e7\u00e3o T\u00e9cnica, incluindo vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o (PMS), adaptado \u00e0s suas necessidades e dispositivos, de acordo com os requisitos da MDR 2017\/745 e EN ISO 13485. Gest\u00e3o de projetos de marca\u00e7\u00e3o CE. Documenta\u00e7\u00e3o e compliance UDI.<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p style=%22text-align: center;%22>Regulatory strategy and requirements, feasibility and planning of achievable goals,regulatory intelligence, submissions to authorities, technical translations, opinions and specialized reports.<\/p>\n<p>&nbsp;<\/p>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#416AA4&#8243; header_2_line_height=&#8221;1.7em&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"text-align: center;\">Regulatory strategy and requirements, feasibility and planning of achievable goals,regulatory intelligence, submissions to authorities, technical translations, opinions and specialized reports.<\/p>\n<p>&nbsp;<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8221;\/contactos&#8221; button_text=&#8221;Contact us&#8221; button_alignment=&#8221;center&#8221; button_alignment_tablet=&#8221;left&#8221; button_alignment_phone=&#8221;center&#8221; button_alignment_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.26.0&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;17px&#8221; button_text_color=&#8221;#FFFFFF&#8221; button_bg_color=&#8221;#58A3CB&#8221; button_border_color=&#8221;#58A3CB&#8221; button_border_radius=&#8221;50px&#8221; custom_margin=&#8221;40px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<br \/>\n[\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; make_equal=&#8221;on&#8221; disabled_on=&#8221;off|off|on&#8221; _builder_version=&#8221;4.24.3&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#FFFFFF&#8221; width_tablet=&#8221;&#8221; width_phone=&#8221;100%&#8221; width_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;0px|||||&#8221; 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_builder_version=&#8221;4.26.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;16px&#8221; header_2_font=&#8221;Poppins|||on|||||&#8221; header_2_text_color=&#8221;#416AA4&#8243; header_2_line_height=&#8221;1.7em&#8221; custom_margin=&#8221;||20px|||&#8221; custom_margin_tablet=&#8221;||20px|||&#8221; custom_margin_phone=&#8221;-72px||20px||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;|30px||30px|false|true&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;18px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2 style=\"text-align: center;\">MARKET ACCESS<\/h2>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<p>Contactos com autoridades competentes e organismos notificados, projetos de licenciamento de atividades de fabrico e distribui\u00e7\u00e3o, registo EUDAMED e bases de dados nacionais.<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p style=%22text-align: center;%22>Strategy and management of price requests, reimbursement and prior hospital assessment, EAP, PICO matrix and value dossier, <span>systematic literature review and NMA, <\/span>contract negotiation, price review and change.<\/p>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#416AA4&#8243; text_font_size=&#8221;16px&#8221; header_2_line_height=&#8221;1.7em&#8221; custom_padding=&#8221;|30px||30px|false|true&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"text-align: center;\">Strategy and management of price requests, reimbursement and prior hospital assessment, EAP, PICO matrix and value dossier, <span>systematic literature review and NMA, <\/span>contract negotiation, price review and change.<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8221;\/contactos&#8221; button_text=&#8221;Contact us&#8221; button_alignment=&#8221;center&#8221; button_alignment_tablet=&#8221;left&#8221; button_alignment_phone=&#8221;center&#8221; button_alignment_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.26.0&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;17px&#8221; button_text_color=&#8221;#FFFFFF&#8221; button_bg_color=&#8221;#58A3CB&#8221; button_border_color=&#8221;#58A3CB&#8221; button_border_radius=&#8221;50px&#8221; custom_margin=&#8221;40px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<br \/>\n[\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; make_equal=&#8221;on&#8221; disabled_on=&#8221;off|off|on&#8221; _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#FFFFFF&#8221; width_tablet=&#8221;&#8221; width_phone=&#8221;100%&#8221; width_last_edited=&#8221;on|phone&#8221; custom_margin_tablet=&#8221;&#8221; custom_margin_phone=&#8221;-40px||||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;0px|||||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.3&#8243; _module_preset=&#8221;default&#8221; background_image=&#8221;https:\/\/xtrategicalpharma.com\/wp-content\/uploads\/2024\/04\/shutterstock_1753637609.jpg&#8221; custom_padding=&#8221;300px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider show_divider=&#8221;off&#8221; _builder_version=&#8221;4.24.3&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<br \/>\n[\/et_pb_divider][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;80px||80px||true|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text content_tablet=&#8221;<\/p>\n<h2><strong>Apoio \u00e0s empresas de Suplementos Alimentares <\/strong><\/h2>\n<p>&#8221; content_phone=&#8221;<\/p>\n<h2 style=%22text-align: center;%22>QUALITY MANAGEMENT SYSTEM<\/h2>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_2_font=&#8221;Poppins|500||on|||||&#8221; header_2_text_color=&#8221;#416AA4&#8243; header_2_line_height=&#8221;1.7em&#8221; custom_margin=&#8221;||20px|||&#8221; custom_margin_tablet=&#8221;||20px|||&#8221; custom_margin_phone=&#8221;-64px||||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;|0px||0px|false|true&#8221; custom_padding_tablet=&#8221;|0px||0px|false|true&#8221; custom_padding_phone=&#8221;|30px||30px|false|true&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; hover_enabled=&#8221;0&#8243; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;18px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2 style=\"text-align: center;\">Sistema de Gest\u00e3o da Qualidade e Procedimentos<\/h2>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<p>Notifica\u00e7\u00e3o de novos produtos em pa\u00edses da Uni\u00e3o Europeia e registo em mercados internacionais, certificados de venda livre, manuten\u00e7\u00e3o do ciclo de vida dos produtos, intera\u00e7\u00f5es com autoridades competentes e outras entidades (e.g. em Portugal: DGAV, DRAP, CIAV, ANF, ASAE), avalia\u00e7\u00e3o de rotulagens, avalia\u00e7\u00e3o e aconselhamento sobre alega\u00e7\u00f5es nutricionais e de sa\u00fade, auditorias internas e acompanhamento de inspe\u00e7\u00f5es, registo SIPACE, regulariza\u00e7\u00e3o de atividades de fabrico e de distribui\u00e7\u00e3o, regulatory intelligence, implementa\u00e7\u00e3o e auditorias de sistemas de gest\u00e3o HACCP e ISO 22000.<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p style=%22text-align: center;%22>Implementation and support in the maintenance of Quality Management Systems, Technical Management and Good Practices (BPX), streamlining processes, writing procedures and forms.<\/p>\n<p>&nbsp;<\/p>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#416AA4&#8243; text_font_size=&#8221;16px&#8221; header_2_line_height=&#8221;1.7em&#8221; custom_padding=&#8221;|30px||30px|false|true&#8221; hover_enabled=&#8221;0&#8243; text_font_size_tablet=&#8221;16px&#8221; text_font_size_phone=&#8221;14px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243; custom_margin=&#8221;||1px|||&#8221;]<\/p>\n<p style=\"text-align: center;\">Implementa\u00e7\u00e3o e suporte na manuten\u00e7\u00e3o de Sistemas de Gest\u00e3o da Qualidade, Dire\u00e7\u00e3o T\u00e9cnica e Boas Pr\u00e1ticas (BPX), agiliza\u00e7\u00e3o de processos, reda\u00e7\u00e3o de procedimentos e formul\u00e1rios.<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8221;\/contactos&#8221; 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