ELS Solutions - Investigação & Desenvolvimento

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O nosso processo inclui as seguintes etapas:

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Ao criar e implementar processos de inovação otimizados, capacitamos os nossos clientes com lançamentos antecipados, eficazes e mais lucrativos, garantindo o seu crescimento.

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Dispositivos Médicos I&D/IP

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Projetos e Operações de Ensaio de Produtos Médicos

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Os projetos e operações de ensaio de produtos médicos requerem um planeamento e execução cuidadosos. A ELS Solutions Group pode apoiá-lo com fortes capacidades:

Estratégia e Gestão de Estudos Pré e Pós-Clínicos;
Escrita/tradução médica;
Relatório de Avaliação Clínica (CER);
Estudo e Design Pré-Clínico de Animais;
Ensaios clínicos;
Consultoria consultiva;
Conceção e Gestão de Estudos de Evidência do Mundo Real.

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Vigilância de Dispositivos Médicos

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A gama de serviços inclui, mas não está limitada a:

Consultoria em dispositivos médicos e gestão de projetos, em conformidade com as orientações atuais;
Estabelecimento de acordos contratuais e supervisão adequados;
Gestão de Dados de Segurança e Base de Dados de Segurança Global;
Efeito Adverso de Dispositivos e Avaliação e Acompanhamento de Incidentes com Dispositivos Médicos;
Preparação e apresentação do Relatório de Vigilância de Dispositivos;
Avaliação médica, incluindo pesquisa e revisão bibliográfica;
Nomeação da pessoa responsável pela conformidade regulamentar (PRRC);
Relatórios de resumo periódicos, incluindo Relatórios de Atualização de Segurança de Desenvolvimento (DSUR), Relatórios Periódicos de Atualização de Segurança (PSUR), Relatórios de Avaliação de Risco de Benefícios Periódicos (PBRERs), entre outros;
Auditorias e consultas de Pré-inspeção.

Serviços de Consultoria Pré-Clínica

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A criação de um plano pré-clínico detalhado para os estágios subsequentes do desenvolvimento do seu ativo é crucial. Nossa equipe regulatória não clínica é especializada no desenvolvimento de planos que atendam aos requisitos regulatórios para levar um produto à clínica e além dela. Estes serviços incluem:

Avaliação de dados técnicos, incluindo dados químicos/de fabricação, pré-clínicos e clínicos;
Determinar o procedimento regulatório apropriado e o status legal dos produtos;
Propor estratégias ideais de arquivamento e submissão;
Estabelecer comunicação regular com as autoridades reguladoras para facilitar o cumprimento;
Identificação e gestão de recursos/especialistas externos.

Serviços de Consultoria Clínica

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A nossa equipa de desenvolvimento clínico é especializada na conceção e execução de programas completos de desenvolvimento de produtos. Com uma vasta gama de peritos incluindo médicos, bioestatísticos e cientistas clínicos, a nossa equipa pode ajudar a conceber um plano de desenvolvimento que reduza o risco e maximize o sucesso clínico.

Os nossos serviços de desenvolvimento clínico incluem:

Planos integrados de desenvolvimento de produtos multifuncionais;
Perfis mínimos de produtos-alvo e planos de desenvolvimento clínico associados;
Desenho de ensaio clínico;
Biomarcadores e estratégias diagnósticas complementares;
Estratégias regulatórias globais e regionais;
Desenvolvimento de produtos farmacêuticos e de dispositivos médicos.

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I&D/IP em Medicamentos

Design & Desenvolvimento

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Experiência numa vasta gama de formas farmacêuticas e vias de aplicação:

Substâncias derivadas de plantas e extratos;
Substâncias químicas e semi-sintéticas;
Produtos biológicos e biotecnológicos.

Seleção dos principais materiais de partida e requisitos de BPF/GMP de acordo com as diretrizes aplicáveis;
Definição dos principais atributos críticos das substâncias medicamentosas;
Definição de programas de desenvolvimento de formulação e processos de fabrico, incluindo supervisão e revisão final dos resultados;
Design de qualidade e planeamento do espaço de design;
Programas de desenvolvimento analítico e revisão de protocolos e relatórios de validação;
Transferências de produção e analíticas, incluindo apoio no local;
Seleção de materiais de embalagem e dispositivos médicos para administração;
Design para desenvolvimento e validação de processos, incluindo aumento de escala;
Planeamento e execução de programas de estabilidade para a ICH e outras regiões, incluindo requisitos da cadeia de abastecimento;
Requisitos para o fabrico, análise e distribuição de Medicamentos de Investigação (IMP).

Serviços de Fase Inicial e de Fase Tardia

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A gama de serviços inclui, mas não está limitada a:

Consultoria em dispositivos médicos e gestão de projetos, em conformidade com as orientações atuais;
Estabelecimento de acordos contratuais e supervisão adequados;
Gestão de Dados de Segurança e Base de Dados de Segurança Global;
Efeito Adverso de Dispositivos e Avaliação e Acompanhamento de Incidentes com Dispositivos Médicos;
Preparação e apresentação do Relatório de Vigilância de Dispositivos;
Avaliação médica, incluindo pesquisa e revisão bibliográfica;
Nomeação da pessoa responsável pela conformidade regulamentar (PRRC);
Relatórios de resumo periódicos, incluindo Relatórios de Atualização de Segurança de Desenvolvimento (DSUR), Relatórios Periódicos de Atualização de Segurança (PSUR), Relatórios de Avaliação de Risco de Benefícios Periódicos (PBRERs), entre outros;
Auditorias e consultas de Pré-inspeção.

Serviços de Consultoria Pré-Clínica

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A criação de um plano pré-clínico detalhado para os estágios subsequentes do desenvolvimento do seu ativo é crucial. Nossa equipe regulatória não clínica é especializada no desenvolvimento de planos que atendam aos requisitos regulatórios para levar um produto à clínica e além dela. Esses serviços incluem:

Avaliação de dados técnicos, incluindo dados químicos/de fabricação, pré-clínicos e clínicos;
Determinar o procedimento regulatório apropriado e o status legal dos produtos;
Propor estratégias ideais de arquivamento e submissão;
Estabelecer comunicação regular com as autoridades reguladoras para facilitar o cumprimento;
Identificação e gestão de recursos/especialistas externos.

Serviços de Consultoria Clínica

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Nossa equipe de desenvolvimento clínico é especializada em projetar e executar programas abrangentes de desenvolvimento de produtos. Com uma ampla gama de especialistas, incluindo médicos, bioestatísticos e cientistas clínicos, nossa equipe pode ajudar a projetar um plano de desenvolvimento que reduza o risco e maximize o sucesso clínico.

Os nossos serviços de desenvolvimento clínico incluem:

Planos integrados de desenvolvimento de produtos multifuncionais;
Perfis mínimos de produtos-alvo e planos de desenvolvimento clínico associados;
Desenho de ensaio clínico;
Biomarcadores e estratégias diagnósticas complementares;
Estratégias regulatórias globais e regionais;
Desenvolvimento de produtos farmacêuticos e de dispositivos médicos.

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Outros Serviços

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Regulamentação e Qualidade

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ELS Solutions é uma empresa certificada na Europa, Brasil e América Latina, com forte conhecimento técnico e estratégico em Regulação e Garantia de Qualidade.

Saber mais

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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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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)” 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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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