ELS Solutions - Regulamentação e Qualidade

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Com forte conhecimento técnico e estratégico em Regulação e Garantia de Qualidade.

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Serviço Personalizado Passo a Passo

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O nosso principal objetivo é oferecer soluções estratégicas efectivas e completas mas simples, incluindo registos na Europa, Brasil e no resto da América Latina.

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Europa

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Dispositivos Médicos;
Medicamentos;
Cosméticos;
Suplementos Alimentares;
Canábis Medicinal;
Outros Produtos.

[/fusion_content_box][fusion_content_box title=”Qualidade” backgroundcolor=”#f1f4f6″ hue=”” saturation=”” lightness=”” alpha=”” icon=”fa-arrow-alt-circle-right fas” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”#000000″ circlecolor=”#007aff” circlebordersize=”” circlebordercolor=”#282828″ outercirclebordersize=”” outercirclebordercolor=”#007aff” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Sistemas de Gestão de Qualidade;
Boas Práticas de Distribuição;
Auditorias.

[/fusion_content_box][fusion_content_box title=”Escrita Médica” backgroundcolor=”#f1f4f6″ hue=”” saturation=”” lightness=”” alpha=”” icon=”fa-arrow-alt-circle-right fas” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”#000000″ circlecolor=”#007aff” circlebordersize=”” circlebordercolor=”#282828″ outercirclebordersize=”” outercirclebordercolor=”#007aff” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Elaboração de relatórios técnicos farmacêuticos, clínicos e não-clínicos, de acordo com a legislação em vigor e as boas práticas mais utilizadas.

[/fusion_content_box][fusion_content_box title=”Assessoria Estratégica” backgroundcolor=”#f1f4f6″ hue=”” saturation=”” lightness=”” alpha=”” icon=”fa-arrow-alt-circle-right fas” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”#000000″ circlecolor=”#007aff” circlebordersize=”” circlebordercolor=”#282828″ outercirclebordersize=”” outercirclebordercolor=”#007aff” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Desenvolvimento de estratégias regulamentares para a Europa;
Definição de estratégias para submissão de processos de registo de novos produtos na Europa;
Pareceres sobre estratégias regulamentares;
Gestão de projetos;
Scientific advice Roadmaps.

[/fusion_content_box][fusion_content_box title=”Vigilância” backgroundcolor=”#f1f4f6″ hue=”” saturation=”” lightness=”” alpha=”” icon=”fa-arrow-alt-circle-right fas” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”#000000″ circlecolor=”#007aff” circlebordersize=”” circlebordercolor=”#282828″ outercirclebordersize=”” outercirclebordercolor=”#007aff” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Vigilância de Dispositivos Médicos;
Farmacovigilância;
Cosmetovigilância;
Nutrivigilância.

[/fusion_content_box][fusion_content_box title=”Acesso ao mercado” backgroundcolor=”#f1f4f6″ hue=”” saturation=”” lightness=”” alpha=”” icon=”fa-arrow-alt-circle-right fas” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”#000000″ circlecolor=”#007aff” circlebordersize=”” circlebordercolor=”#282828″ outercirclebordersize=”” outercirclebordercolor=”#007aff” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Desenvolvimento de estratégia para pedidos de preço e comparticipação de medicamentos;
Preparação, submissão e gestão de pedidos de preço;
Revisão Anual de Preços, de acordo com as diretrizes emitidas pelas Autoridades Nacionais Competentes;
Pedidos de Revisão Excecional de Preço;
Pedidos de alteração de preço – Regime de preços notificados;
Preparação, submissão e gestão de pedidos de comparticipação;
Elaboração de dossier de vantagem terapêutica;
Elaboração de relatórios farmacoterapêuticos;
Elaboração de relatório de perito clínico;
Elaboração de estudos farmacoeconómicos.

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LATAM

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Boas Práticas de Fabricação e Laboratório;
Sistemas de Gestão de Qualidade (SGQ);
Certificações INMETRO;
Certificação ISO.

[/fusion_content_box][fusion_content_box title=”Assuntos Regulamentares” backgroundcolor=”#f1f4f6″ hue=”” saturation=”” lightness=”” alpha=”” icon=”fa-arrow-alt-circle-right fas” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”#000000″ circlecolor=”#007aff” circlebordersize=”” circlebordercolor=”#282828″ outercirclebordersize=”” outercirclebordercolor=”#007aff” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Dispositivos Médicos;
Medicamentos;
Cosméticos;
Alimentos;
Canábis Medicinal;
Saneantes;
Produtos de Diagnóstico in Vitro;
Outros Produtos.

Elaboração de relatórios farmacêuticos, clínicos e não-clínicos, conforme legislações vigentes brasileiras, em âmbito regulatório e da qualidade.

Na ELS Solutions possuímos profissionais com experiência internacional para auxiliar a sua empresa através da:
- Realização de um plano regulatório para a entrada de produtos no mercado brasileiro e assessoria dos mesmos;
- Definição de estratégias para a submissão de processos de registro de novos produtos;
- Pareceres sobre estratégias regulamentares;
- Gestão de projetos;
- Conselheiro científico;
- Roadmaps.

Vigilância de Dispositivos Médicos;
Farmacovigilância;
Cosmetovigilância;
Serviços de Vigilância para Canábis Medicinal;
Serviços de Vigilância de Alimentos;
Serviços de Vigilância de Saneantes;
Serviços Vigilância de Produtos de Diagnóstico in vitro.

O processo de Market Access vincula os requisitos a nível global e às necessidades ao nível do país local. Precisando de processos de:
- Identificação do valor, com base nas informações do consumidor;
- Criação de valor por meio de dados clínicos e de saúde sobre resultados económicos e pesquisas;
- Comunicação de valor por meio da Proposição de Valor e Dossiê de Valor, para os departamentos de P&D e Comerciais.
Nós da ELS Solutions possuímos profissionais com experiência internacional auxiliando a sua empresa com a introdução de seu produto no mercado brasileiro, criando um plano de Market Access:
- Elaboração de estudos farmacoeconómicos;
- Desenvolvimento e planejamento de estratégias para o acesso ao mercado brasileiro;
- Elaboração de relatórios farmacoterapêuticos;
- Acompanhamento de todo o processo de introdução do produto no mercado brasileiro, além do pós-mercado.
Elaboração de estudos farmacoeconómicos.

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AGÊNCIAS REGULADORAS

[/fusion_title][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”center” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”20″ line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

ELS Group é uma empresa reguladora certificada na Europa, Brasil e América Latina, com forte conhecimento técnico e estratégico em Assuntos Regulamentares e Garantia de Qualidade. Estamos presentes em 11 países, com uma equipa local de Assuntos Regulamentares e Qualidade que trabalha com as seguintes agências reguladoras:

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ARGENTINA: Administração Nacional de Medicamentos, Alimentação e Tecnologia Médica (ANMAT)
BRASIL: Agência Nacional de Vigilância Sanitária (ANVISA)
CHILE: Agência Nacional de Medicamentos (ANAMEd)
COLÔMBIA: Instituto Nacional de Vigilância de Medicamentos e Alimentos (INVIMA)
MÉXICO: Comissão Federal para a Proteção contra os Riscos para a Saúde (COFEPRIS)
EUROPA: Agência Europeia de Medicamentos (EMA)
PORTUGAL: Autoridade Nacional do Medicamento e Produtos de Saúde I.P. (INFARMED)
FRANÇA: Agência Nacional de Segurança dos Medicamentos e Produtos de Saúde (ANSM)
ESPANHA: Agência Espanhola de Medicamentos e Produtos de Saúde (AEMPS)
REINO UNIDO: Agência Reguladora dos Medicamentos e Produtos de Saúde (MHRA)
ITÁLIA: Agência Italiana de Medicamentos (AIFA)
ALEMANHA: Instituto Federal da Droga e dos Dispositivos Médicos (BfArM)

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Outros serviços

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Headhunting de Distribuidores

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Encontramos e gerenciamos o melhor distribuidor para a sua empresa, considerando sua necessidade, produto e público em toda Europa e América Latina.

Saber mais

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Importação

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A ELS Solutions fornece um serviço robusto de Importação, Armazenagem, Faturação e Atendimento ao Cliente, nos países em que está representada, para que o cliente controle os seus negócios, a sua margem e não precise de depender do distribuidor, concentrando-se no aumento das vendas.

Saber mais

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Assessoria de Marketing

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A ELS Solutions realiza para a sua empresa Estudos de Mercado realistas, pragmáticos e customizados ao seu produto ou serviço no mercado-alvo, na Europa e América Latina.

Saber mais

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Entre em contato conosco

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O seu sucesso é o nosso negócio

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filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_position=”all” element_content=”” type_medium=”2_5″ first=”false” min_height=”” link=””][fusion_button link=”https://els-solutions.com/onde-estamos/” title=”” target=”_self” link_attributes=”” alignment_medium=”” alignment_small=”” alignment=”center” modal=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” color=”default” button_gradient_top_color=”” hue=”” saturation=”” lightness=”” alpha=”” button_gradient_bottom_color=”” button_gradient_top_color_hover=”” button_gradient_bottom_color_hover=”” gradient_start_position=”” gradient_end_position=”” gradient_type=”” radial_direction=”” linear_angle=”” accent_color=”” accent_hover_color=”” type=”” bevel_color=”” bevel_color_hover=”” border_top=”” border_right=”” border_bottom=”” border_left=”” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” border_color=”” border_hover_color=”” size=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” fusion_font_family_button_font=”” fusion_font_variant_button_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” stretch=”yes” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” icon=”” icon_position=”left” icon_divider=”no” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Contacte-nos [/fusion_button][fusion_button link=”tel:+351214525038″ title=”” target=”_self” link_attributes=”” alignment_medium=”” alignment_small=”” alignment=”center” modal=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” color=”custom” button_gradient_top_color=”var(–awb-custom1)” hue=”” saturation=”” lightness=”” alpha=”” button_gradient_bottom_color=”var(–awb-custom1)” button_gradient_top_color_hover=”var(–awb-color1)” button_gradient_bottom_color_hover=”var(–awb-color1)” gradient_start_position=”” gradient_end_position=”” gradient_type=”” radial_direction=”” linear_angle=”” accent_color=”var(–awb-color7)” accent_hover_color=”var(–awb-color7)” type=”” bevel_color=”” bevel_color_hover=”” border_top=”” border_right=”” border_bottom=”” border_left=”” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” border_color=”var(–awb-color7)” border_hover_color=”var(–awb-color7)” size=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” fusion_font_family_button_font=”” fusion_font_variant_button_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” stretch=”yes” margin_top=”12px” margin_right=”” margin_bottom=”” margin_left=”” icon=”fusion-prefix-icon-accountant-call-us” icon_position=”left” icon_divider=”no” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]+351 21 452 50 38[/fusion_button][fusion_button link=”https://wa.me/5511992792618″ title=”” target=”_self” link_attributes=”” alignment_medium=”” alignment_small=”” alignment=”center” modal=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” color=”custom” button_gradient_top_color=”var(–awb-custom1)” hue=”” saturation=”” lightness=”” alpha=”” button_gradient_bottom_color=”var(–awb-custom1)” button_gradient_top_color_hover=”var(–awb-color1)” button_gradient_bottom_color_hover=”var(–awb-color1)” gradient_start_position=”” gradient_end_position=”” gradient_type=”” radial_direction=”” linear_angle=”” accent_color=”var(–awb-color7)” accent_hover_color=”var(–awb-color7)” type=”” bevel_color=”” bevel_color_hover=”” border_top=”” border_right=”” border_bottom=”” border_left=”” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” 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