Isis Valle R. Da Costa Email and Phone Number
Food Regulatory and Strategic Intelligence | Project Management at
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Franklin da Costa Advogados & Consultores
Isis Valle R. Da Costa's Location
Federal District, Brazil, Brazil
Isis Valle R. Da Costa's Contact Details
Isis Valle R. Da Costa personal email
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About Isis Valle R. Da Costa
For more than five years, I have been helping companies in the food chain to make their products regulatory and strategically viable for the Brazilian market. My main areas of expertise are the evaluation of substances for inclusion in the positive lists of ANVISA and the Ministry of Agriculture and Livestock, and food supplements.I have succeeded to obtain ANVISA’s approval for more than twenty substances as ingredients for use in food supplements and conventional foods, as food additives, technology aids (including enzymes) and substances for use in materials in contact with food. My approval rate is over 90% in all petitions, totaling 100% in petitions for the inclusion and extension of the use of food additives and technology aids, 100% in petitions evaluating new substances for materials in contact with food, and 77 % in new ingredient evaluation petitions.*I have already helped large companies include their ingredients and claims on the positive lists for dietary supplements in IN 28/2018. Among them, isolated substances; complex mixtures; synthetic ingredients, of plant, animal, microbial and algae origin; and probiotics.I have also obtained approval for an enzyme as a technology aid for bakery products, a copolymer for coating food supplement capsules, and food additives.Furthermore, I participated in the preparation of petitions for four substances for use in coating regenerated cellulose films that enabled the arrival of compostable coffee capsules in Brazil.I am in charge of the Food Regulatory Intelligence area at Franklin da Costa Advogados & Consultores.We guide you throughout the strategic-regulatory development of your project for the Brazilian market. From the framing of your product and/or company, regulatory assessment of the formulation, regulatory feasibility study of your project, gap analysis, determination and execution of regularization strategies, guidelines for imports, regulatory guidelines for R&D and Marketing, to responses from requirements and notices of infringement until labeling and notification of the start of manufacturing and/or import.* Among the petitions with a positive feasibility study.
Isis Valle R. Da Costa's Current Company Details
Franklin Da Costa Advogados & Consultores
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Food Regulatory and Strategic Intelligence | Project Management
Isis Valle R. Da Costa Work Experience Details
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Senior Regulatory SpecialistFranklin Da Costa Advogados & Consultores Jun 2023 - PresentBrasília, Federal District, BrazilRegulatory and Scientific Intelligence in Dietary Supplements, Food and Beverages
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Teacher Of The Audit Systems For Food Consultants CourseIbcali - Instituto Brasileiro De Consultoria De Alimentos Apr 2023 - PresentCritical presentation of the Brazilian legal basis for inspection, auditing and supervision of the food industry, food services and mass events. Types of audits and principles of Hazard Analysis and Critical Control Points (HACCP). How to prepare for inspections of establishments and products regulated by the National Health Surveillance Agency (Anvisa), and by the Ministry of Agriculture and Livestock (Mapa). How to conduct internal audits and how to prepare to receive external audits. How to obtain voluntary certifications.
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Food, Beverages, And Dietary Suplements Regulatory Affairs ManagerVisanco - Consultoria Em Assuntos Regulatórios Na Área De Vigilância Sanitária Dec 2022 - Apr 2023Brasília, Federal District, BrazilResponsabilities:- Inbound sales: identifying and connecting with customers to provide tailored solutions.- Building strong relationships with customers to deliver great satisfaction with a problem-solving mentality applied to regulatory intelligence in health surveillance to attract and retain these customers, do business, increase market share, stay ahead of competition, and grow revenues and operations. - Solidification of the governance structure, standard operation procedures, processes flows and processes in the company’s Food, Beverage and Dietary Supplements department.- Leading a team of six people responsible for the strategic regulatory roadmaps of food, beverage, food supplements, food contact material products and ingredients to a wide range of national and international stakeholders to assure compliance with Brazilian regulations. - Managing of a portfolio of around thirteen accounts of continuous regulatory assistance subscribers, providing regulatory advice and information on substance, product and company levels, support for product development teams, advice on ingredients, formulations, and for label, product information and communication material compliance, and monitoring regulatory developments and trends.- Managing of around twenty simultaneous regulatory projects, leading and performing detailed reviews of regulatory risk assessments, safety and efficacy submissions, formulations evaluations, labeling statements, artworks and promotional material reviews, and regulatory opinions. -
Food, Beverages, And Dietary Suplements Regulatory Affairs CoordinatorVisanco - Consultoria Em Assuntos Regulatórios Na Área De Vigilância Sanitária Apr 2022 - Nov 2022Brasília, Federal District, BrazilResponsabilities:- Leading of a team of six people in the setting up of food, beverage, food supplements, food contact material products and ingredients strategic regulatory roadmaps to a wide range of national and international stakeholders to assure compliance with Brazilian regulations. - Implementation of a governance structure, standard operation procedures, processes flows and processes.- Managing of a portfolio of around ten accounts of continuous regulatory assistance subscribers, providing regulatory advice and information on substance, product and company levels, support for product development teams, advice on ingredients, formulations, and for label, product information and communication material compliance, and monitoring regulatory developments and trends.- Managing of around twenty simultaneous regulatory projects, leading and performing detailed reviews of regulatory risk assessments, safety and efficacy submissions, formulations evaluations, labeling statements, artworks and promotional material reviews, and regulatory opinions.Main Achievements: - Approval of four substances for the manufacture of compostable coffee capsules.- Approval of the claim “Lactobacillus rhamnosus GG (DSM 33156) may contribute to the health of the gastrointestinal tract” for a lower dose for dietary supplements.- First authorization to supplement the bioactive compound glucosamine with the approval of a glucosamine hydrochloride obtained from fermentation.- Approval of a maltogenic alfa-amylase enzyme from a genetically modified organism for use in bakery products.- First approval of a yeast trans-resveratrol in Brazil.
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Food, Beverages, And Dietary Suplements Regulatory Affairs SupervisorVisanco - Consultoria Em Assuntos Regulatórios Na Área De Vigilância Sanitária Sep 2020 - Mar 2022Brasília, Federal District, BrazilResponsibilities:- Restructuration of the area, including the hiring and training of personnel and putting in place a governance structure, standard operation procedures and processes flows.- Technical and strategic support for inbound sales. - Managing of a team of eight people.- Managing of around twenty simultaneous projects, from understanding the clients and other stakeholders’ needs to coordinating the tasks of distributed remote project teams, detailed revision for quality control of all tasks and project progress monitoring.- Account management of around ten accounts of continuous regulatory assistance subscribers with revision of the orientations provided to address all requests from stakeholders (manufactures, distributors, importers, artwork agencies) on (new) food, beverage, dietary supplements and ingredients products development and regularization.- Coordination and moderation of meetings and calls with clients, other stakeholders, the team, and regulatory authorities to ensure appropriate communication takes place to complete all projects in an efficient manner.- Supervision and detailed revision of simplified systematic reviews of the scientific literature for efficacy assessment submissions requesting the approval of functional claims to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA).- Leading the contributions to ANVISA public consultations.Main Achievements: - Inclusion of the update of the Brazilian norm for regenerate cellulose films intended to come into contact with food in ANVISA’s 2021-2023 regulatory agenda and in the MERCOSUL agenda.- First approval of a whole-food source of Vitamin D in Brazil with the inclusion of a vitamin D-enhanced mushroom in ANVISA’s IN 28/2018 positive list.- Establishment of standard regulatory procedures and projects and clients tracking tools.
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Junior Food, Beverages, And Dietary Suplements Regulatory Affairs AnalystVisanco - Consultoria Em Assuntos Regulatórios Na Área De Vigilância Sanitária Jan 2020 - Aug 2020Brasília, Federal District, BrazilResponsibilities: - Project management in three different areas: 1) safety and efficacy assessment submissions to the Brazilian Health Surveillance Agency for the request of a wide-variety of new ingredients or food additives; 2) gap analysis of a wide-variety of new food supplements ingredients and functional claims’ compliance with Brazilian requirements; 3) food products and food supplements formulation regulatory analysis followed by the writing of the labeling statements and the labeling art revision for two different brands.- Account management: responsible for the regulatory demands (mostly food supplements formulation analysis, label statements and nutritional table writing, labelling art revision, and specific regulatory doubts) of a client from the sector of dietary supplements import.- Coordination of content creation (webinars, talks and social media) on Brazilian regulatory requirements for presentation to food, beverage, food supplements and ingredients stakeholders.Main Achievements:- First approval of algae-sourced beta-glucans for use in food supplements in Brazil with the inclusion of a whole cell algae and of isolated beta-glucans in ANVISA’s IN 28/2018 positive list.- First approval of a powdered omega-3 for use in food supplements in Brazil with the inclusion of an omega-3 fatty acid lysine complex in ANVISA’s IN 28/2018 positive list.- Reformulation of the company’s food area system to track regulatory submissions to the Brazilian Health Surveillance Agency.- Setting up of systems to analyze food products and food supplement formulations’ compliance to positive lists and limits of use.- Setting up of a system to automatically calculate nutrition facts tables.
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Food, Beverages, And Dietary Suplements Regulatory Affairs Analyst TraineeVisanco - Consultoria Em Assuntos Regulatórios Na Área De Vigilância Sanitária Jan 2019 - Dec 2019Brasília Area, BrazilResponsibilities: - Content creation (webinars, talks and social media) on Brazilian regulatory requirements for presentation to food, beverage, dietary supplements and ingredients stakeholders.- Project management in three different areas: 1) Safety and efficacy assessment submissions to the Brazilian Health Surveillance Agency for the request of a new ingredients or food additives for use in food supplements; 2) Gap analysis of new food supplements ingredients and functional claims’ compliance with Brazilian requirements; 3) Food products and food supplements formulation regulatory analysis followed by the writing of the labeling statements and the labeling art revision for two different brands.- Account management: responsible for the regulatory demands (mostly food supplements formulation analysis, label statements and nutritional table writing, labelling art revision, and specific regulatory doubts) of a client from the sector of dietary supplements import.- Constant monitoring, analysis, interpretation and implementation of applicable food law and other regulatory requirements such as international standards and norms.- Writing and/or review, compilation, submission and tracking of administrative, technical, and scientific documents for different regulatory procedures.Main Achievements: - First authorization to supplement the mineral boron in the form of food supplements in Brazil with the inclusion of sodium tetraborate decahydrate in ANVISA’s IN 28/2018 positive list.- Approval of anionic methacrylate copolymer for use in the coating of food supplements in Brazil as a glazing agent to provide moisture protection and to mask the taste of various nutrients present in the treated products.- A one-hundred-fold augmentation in the level of permitted use of sodium ascorbate in food supplements for children in Brazil to cover the amount needed for use as cryoprotectant in probiotics lyophilization.
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Food, Beverages, And Dietary Suplements Regulatory Affairs InternVisanco - Consultoria Em Assuntos Regulatórios Na Área De Vigilância Sanitária Jul 2018 - Dec 2018Brasília Area, BrazilResponsibilities: - Content creation (webinars, talks and social media) for presentation to food, beverage, dietary supplements and ingredients industry stakeholders on Brazilian regulatory requirements.- Project management assistance: support in the management of one large project for the safety and efficacy assessment submission of a new ingredient for use in food supplements to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA).- Regulatory and scientific literature review to support food safety and efficacy assessment submissions.- Tracking of (new) food products regularization processes in the Brazilian Health Surveillance Agency.Main Achievements: - Webinars and talks to update to food, beverage, food supplements and ingredients industry stakeholders on the all-new Brazilian food supplements framework (a set of six norms published in July 2018).
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Project ManagerUniversidade De Brasília May 2017 - Feb 2019Brasília Area, BrazilProject manager of the production of a series of educational histology videos on exocrine glands for the Institute of Biological Sciences in Portuguese and English.- Benchmark of the histology educational videos available online.- Writing of the funding proposal for the Brazilian Research Support Foundation (Fundação de de Apoio à Pesquisa - FAPDF) covering the need for the project; detailed project plan, including, goals, objectives, detailed tasks, and timeline; and required equipment, consumables, personnel and budget.- Hiring and management of internal and outsourced personnel: undergraduate researcher, intern, illustrators, translators, announcer, sound engineer, video editors, etc.- Pre-production: study and selection of content, scripts writing, creation of storyboards, and supervision of histological slides light microscopy images production and of content translations.- Production: direction of the production of illustrations, recording of voiceovers, and editing and animation. -
Coordinator Of The Histology Tutoring Program And TutoressUniversidade De Brasília Apr 2016 - Dec 2016Brasília Area, Brazil- Setup of the Histology Tutoring Program of the Institute of Biological Sciences for extra class assistance to Histology and related disciplines students, including governance setup, and team and schedule management. - Extra class and in class assistance to students.
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Digital Content CreatorUniversidade De Brasília May 2015 - Sep 2015Brasília Area, Brazil- Production of e-learning food and nutrition courses focused on public health for health care professionals of the Brazilian Health Care System (Sistema Único de Saúde - SUS) in partnership with the Brazilian Department of Health and the Pan American Health Organization (PAHO/WHO).- Social media management for the Brazilian Health Care System Social Network - RedeNutri.
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Food Regulatory Affairs InternVisanco - Consultoria Em Assuntos Regulatórios Na Área De Vigilância Sanitária Oct 2014 - Apr 2015Brasília, Distrito Federal, BrazilResponsibilities: - Regulatory and scientific literature review to support new food evaluation regulatory submissions to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA).- Writing of newsletters for the food, beverage and ingredients industry stakeholders (manufactures, distributors, importers).- Tracking of [new] food product registration processes in the Brazilian Health Surveillance Agency.Main Achievements: - Setup of a tutorial for the tracking of new food product registration processes in the Brazilian Health Surveillance Agency.- Reformulation of the newsletter for the food, beverage, and ingredients industry stakeholders (manufactures, distributors, importers).
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Sales CashierBio Génération Organic Market Oct 2009 - Mar 2010Paris, Île-De-France, FranceCash register operations, merchandising and counseling customers on organic and natural products.
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Digital Marketing InternNurun Apr 2009 - Sep 2009Paris Area, France- Technology watch and web analytics for key accounts such as Château de Versailles (www.chateauversailles.fr) and Tag Heuer (www.tagheuer.com).- Responsible for the global intranet and corporate news. -
Front Desk AgentHotel Acácias Saint Germain Othon Classic Apr 2007 - Apr 2009Paris, Île-De-France, France- Inbound sales (rooms, transport, tours, tickets to local attractions). - Coordination of the daily activities of the hotel staff (housekeeping and maintenance).- General administrative and secretarial support.- Front office reception.- Sales of tours and tickets to local attractions.
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Digital Marketing InternEdf R&D Apr 2008 - May 2008Paris Area, France- Commercial website innovation team assistant for http://edfentreprises.fr. - Benchmark of electricity companies' websites in Portuguese, Spanish, English and French.- Optimizations recommendations for http://edfentreprises.fr. -
Public RelationsChamber Of Deputies In The Federal District (Brazil) Jan 2006 - Jul 2006Brasília Area, BrazilPromotion of politicians’ activities by press release writing, website update and press reception.
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ReporterTribuna Do Brasil Mar 2005 - Dec 2005Brasília Area, BrazilPolice reporter.
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Production ManagerZoona Z Rock Tv Jul 2003 - Oct 2003Brasília Area, BrazilLocal rock themed TV show production.
Isis Valle R. Da Costa Skills
Editorial
Public Relations
Digital Media
Social Media
Newspapers
Microsoft Office
Management
Adobe Photoshop
Digital Marketing
Wordpress
Indesign
Research
Editing
Press Releases
English
Health
Holistic Health
Social Media Marketing
Photoshop
Photography
Web Analytics
Writing
Isis Valle R. Da Costa Education Details
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Journalism
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Journalism
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Creative Industries: Media, Web, And Arts -
Digital Communication: Project Management And Technology Watch
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Communication, Informatique Et Multimédia
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Université Stendhal (Grenoble Iii)Information And Communication -
Nutrition Sciences
Frequently Asked Questions about Isis Valle R. Da Costa
What company does Isis Valle R. Da Costa work for?
Isis Valle R. Da Costa works for Franklin Da Costa Advogados & Consultores
What is Isis Valle R. Da Costa's role at the current company?
Isis Valle R. Da Costa's current role is Food Regulatory and Strategic Intelligence | Project Management.
What is Isis Valle R. Da Costa's email address?
Isis Valle R. Da Costa's email address is is****@****ail.com
What schools did Isis Valle R. Da Costa attend?
Isis Valle R. Da Costa attended Universidade De Brasília, Universidade De Brasília, Université Vincennes-Saint-Denis (Paris Viii), Université Vincennes-Saint-Denis (Paris Viii), Université Vincennes-Saint-Denis (Paris Viii), Université Stendhal (Grenoble Iii), Universidade De Brasília.
What are some of Isis Valle R. Da Costa's interests?
Isis Valle R. Da Costa has interest in Yoga, Healthy Eating And Lifestyle, Photography, Cinema.
What skills is Isis Valle R. Da Costa known for?
Isis Valle R. Da Costa has skills like Editorial, Public Relations, Digital Media, Social Media, Newspapers, Microsoft Office, Management, Adobe Photoshop, Digital Marketing, Wordpress, Indesign, Research.
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