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With strong technical and strategic expertise in Regulation and Quality Assurance.
[/fusion_title][fusion_content_boxes layout=”icon-on-side” columns=”1″ alignment=”” link_type=”” button_span=”” link_area=”” link_target=”” icon_align=”left” animation_type=”” animation_direction=”down” animation_color=”” hue=”” saturation=”” lightness=”” alpha=”” animation_speed=”0.6″ animation_delay=”500″ animation_offset=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” title_size=”” heading_size=”3″ title_color=”” body_color=”” backgroundcolor=”” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” icon=”” iconflip=”” iconrotate=”” iconspin=”no” iconcolor_hover=”” iconcolor=”” icon_circle=”no” icon_circle_radius=”20px” circlecolor_hover=”” circlecolor=”var(–awb-color3)” circlebordersize=”0″ circlebordercolor=”” outercirclebordersize=”” 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animation_offset=”” /][fusion_content_box title=” Rational writing, compilation, and submission of the technical dossier for registration” backgroundcolor=”” hue=”” saturation=”” lightness=”” alpha=”” icon=”fa-check fas” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][/fusion_content_boxes][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” 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Personalized Step-by-Step Service
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Our main goal is to provide effective and comprehensive yet simple strategic solutions, including registrations in Europe, Brazil, and the rest of Latin America.
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Europe
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Quality
[/fusion_title]
- Quality Management Systems;
- Good Distribution Practices;
- Audits.
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Regulatory Affairs
[/fusion_title]
- Medical Devices;
- Medicines;
- Cosmetics;
- Dietary Supplements;
- Medical Cannabis;
- Other Products.
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Medical Writing
[/fusion_title]
Preparation of pharmaceutical, clinical, and non-clinical technical reports in accordance with current legislation and best practices.
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Strategic Consulting
[/fusion_title]
- Development of regulatory strategies for Europe;
- Definition of strategies for submission of registration processes for new products in Europe;
- Opinions on regulatory strategies;
- Project management;
- Scientific advice Roadmaps.
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Vigilance
[/fusion_title]
- Medical Device Vigilance;
- Pharmacovigilance;
- Cosmetovigilance;
- Nutrivigilance.
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Market Access
[/fusion_title]
- Development of strategy for pricing and reimbursement applications for pharmaceuticals.
- Preparation, submission, and management of pricing applications.
- Annual Price Review in accordance with guidelines issued by Competent National Authorities.
- Exceptional Price Review requests.
- Price amendment requests under the Notified Prices regime.
- Preparation, submission, and management of reimbursement applications.
- Development of therapeutic advantage dossiers.
- Preparation of pharmacotherapeutic reports.
- Preparation of clinical expert reports.
- Conducting pharmacoeconomic studies.
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LATAM
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Quality
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- Good Manufacturing and Laboratory Practices;
- Quality Management Systems (QMS);
- INMETRO certifications;
- ISO certifications.
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Regulatory Affairs
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- Medical Devices;
- Medicines;
- Cosmetics;
- Food;
- Medical Cannabis;
- Sanitizing products;
- In Vitro Diagnostic Products;
- Other Products.
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Medical Writing
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Preparation of pharmaceutical, clinical, and non-clinical reports in accordance with current Brazilian and Latin American regulations, in regulatory and quality contexts.
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Strategic Consulting
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At ELS Solutions, we have professionals with international experience to assist your company through:
- Development of a regulatory plan for market entry of products in Brazil and Latin America and advisory services for the same.
- Definition of strategies for submission of registration processes for new products.
- Regulatory strategy opinions.
- Project management.
- Scientific advisory.
- Roadmaps.
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Vigilance
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- Medical Device Surveillance;
- Pharmacovigilance;
- Cosmetovigilance;
- Medical Cannabis Surveillance Services;
- Food Surveillance Services;
- Sanitary Surveillance Services;
- In Vitro Diagnostic Products Surveillance Services.
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Market Access
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The Market Access process links global requirements with local country needs, requiring the following processes:
- Value identification based on consumer information.
- Value creation through clinical and health data on economic outcomes and research.
- Value communication through Value Proposition and Value Dossier for R&D and Sales departments.
At ELS Solutions, we have professionals with international experience to assist your company in introducing your product to the Brazilian and Latin American market, creating a Market Access plan that includes:
- Development and planning of strategies for market access in Brazil and Latin America.
- Preparation of pharmacoeconomic studies.
- Elaboration of pharmacotherapeutic reports.
- Monitoring the entire process of product introduction in the Brazilian market, including post-market activities.
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REGULATORY AGENCIES
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ELS Group is a certified regulatory company in Europe, Brazil and Latin America, with strong technical and strategic expertise in Regulatory Affairs and Quality Assurance. We are present in 11 countries, with a local Regulatory Affairs and Quality team that works with the following regulatory agencies:
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- ARGENTINA: National Administration of Medicines, Food and Medical Technology (ANMAT)
- BRAZIL: National Health Surveillance Agency (ANVISA)
- CHILE: National Medicines Agency (ANAMEd)
- COLOMBIA: National Institute for the Surveillance of Medicines and Food (INVIMA)
- MEXICO: Federal Commission for the Protection against Sanitary Risks (COFEPRIS)
- EUROPE European Medicines Agency (EMA)
- PORTUGAL: Portuguese Medicines and Health Products Authority I.P. (INFARMED)
- FRANCE: National Agency for Medicines and Health Products Safety (ANSM)
- SPAIN: Spanish Agency of Medicines and Health Products (AEMPS)
- UK: Medicines and Healthcare Products Regulatory Agency (MHRA)
- ITALY: Italian Medicines Agency (AIFA)
- ALEMANHA: Federal Institute for Drugs and Medical Devices (BfArM)
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Other services
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Distribution Headhunting
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Aiming at the continuous expansion of the market of the Pharmaceutical and Health Industry companies with which it works, ELS Solutions plans, selects, attracts, negotiates and manages the most suitable distributor(s) for the target product of the customer in Europe and Latin America.
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Importation
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ELS Solutions provides a robust Import, Warehousing, Billing and Customer Service service, in the countries where it is represented, so that the customer controls their business, their margin and does not need to depend on the distributor, focusing on increasing of sales.
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Marketing Advisory
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ELS Solutions carries out realistic, pragmatic and customized Market Studies for your company for your product or service in the target market, in Europe and Latin America.
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Contact us
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Your success is our business
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