CONSULTING AND REGULATORY ADVICE
FOR FOOD AND FOOD SUPPLEMENTS.
KNOWLEDGE
META REGULATÓRIA is a company specialized in the regulatory needs of the food and pharmaceutical industries, with emphasis on food and dietary supplements area. Providing its clients with more than 25 years of experience in the regulatory area, it has a team made up of specialists in food science, pharmaceuticals and nutrition who have a deep understanding of the difficulties that companies face in their routine.
More than a consultancy, META is a company that proposes to be side by side with the client, teaching the way within the regulatory environment, offering solutions, support and alternatives for the regularization and commercialization of the companies' products.
META REGULATÓRIA has a deep understanding of the process because it closely follows the development of Brazilian Regulatory Agency's rules and decisions, from a participatory and argumentative attitude.
OUR MISSION
Provide quality regulatory advice and services, helping companies balance innovation and regulatory compliance in an ethical and efficient manner.
ABOUT US
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PROFESSIONALISM AND EXPERIENCE
META REGULATÓRIA professionals bring together a deep knowledge of technical regulations, regulatory processes and scientific matters concerning foods, beverages and food supplements.
It’s a multidisciplinary team, led by Daniela Tomei (Partner and founder), a pharmacist-biochemist who graduated in 1994 from Universidade de São Paulo USP, with a specialization in Food Science . Since 1995, she has been active in regulatory affairs.
PARTNERS
Verônica
Maschi
Nutritionist graduated from the Methodist University of São Paulo.
Working since 2009 in the area of regulatory affairs, with experience in large multinationals and experience in international legislation, labeling, processes and regulations at ANVISA and the Ministry of Agriculture (MAPA).
Beatriz
Pagotto
Pharmacist, graduated from Faculdade de Medicina do ABC, works in Regulatory Affairs since 2014.
Experience in preparing technical-scientific documentation for approval of new ingredients, probiotics and registration of food supplements, formulas for enteral nutrition, infant formulas and other foods for special purposes.
Larissa
Yokouchi
Nutritionist, graduated from Centro Universitário São Camilo, works in Regulatory Affairs since 2014.
Experience in preparing documentation for food and food supplements registration, general and nutritional labeling analysis and regulatory due diligence.
SERVICES
See below the scope META REGULATÓRIA work
Development of technical-scientific reports for the regularization of novel foods, functional foods, food supplements and probiotics.
Food and Food Supplements’ registration and notification at ANVISA.
Beverages and products of animal origin’s registration at the Ministry of Agriculture (MAPA).
Online and “In-company” courses about food legislation, regulation and labeling requirements.
Technical defenses developments for response to notifications and infraction notices.
Request for extension/approval of food additives in ANVISA.
Formula and labels evaluation for national and imported products to verify compliance with Brazilian legislation.
Documents evaluation to prove the safety of new ingredients and functional claims - gap analysis and due diligence.
Preparation of reports and risk analysis for the Marketing and R&D departments.
Regulatory compliance assessment of advertising material and packaging.
Solution of regulatory technical doubts on the application of ANVISA, Ministry of Agriculture and INMETRO standards.
Labeling and Nutritional facts Analysis.
OUR CUSTOMERS IN EVIDENCE
We follow each regulatory challenge together with the client so that your products and services are available to the market in a solid, fast and efficient way. This is the success of META REGULATÓRA.
CASES
60%
Responsible by 60% of the probiotic processes approved by ANVISA after the publication of the new regulatory framework for Probiotics, with several functional claims, such as intestinal health, cholesterol reduction, stress and anxiety and reduced risk of atopic dermatitis.
High rate of positive results in proof of safety and efficacy submissions for novel ingredients sources of bioactive substances.
Approval of ingredient’s functional claims like “Joint health” and “Vision Health”.
Approval of several enteral nutrition products.
CONTACT
Av. Moema, 94 - Conj. 83 - Indianópolis
São Paulo - SP | 04077-908 | Tel.: +55 11 2532-2743