Exhibiting at Fi South America 2025

Regularium is a Brazil-based consultancy firm specializing in regulatory intelligence and compliance solutions for companies operating within the food and health sectors. Headquartered in Brasília, Regularium plays a pivotal role in guiding businesses through the intricate landscape of Brazilian regulatory frameworks, primarily governed by ANVISA (Agência Nacional de Vigilância Sanitária) and MAPA (Ministério da Agricultura, Pecuária e Abastecimento). ## Core Business and Offerings Regularium delivers a focused suite of regulatory services that ensure clients remain compliant with Brazilian legislation. Their core offerings include: - Regulatory Strategy & Planning Comprehensive planning to align product development and market entry with Brazilian regulatory requirements. - Dossier Preparation and Submission Expertise in assembling, reviewing, and submitting documentation to ANVISA and MAPA, significantly reducing turnaround times. - Post-Market Surveillance Support Ongoing monitoring of regulatory updates, adverse event reporting, and recall management protocols. - Labeling and Claims Compliance Ensures packaging and marketing materials meet legal standards for health and nutrition claims. - Training & Workshops Educational programs designed to upskill in-house regulatory affairs teams. ## Specialisation and Core USP Regularium's core strength lies in its deep specialization in Brazilian food and health regulatory frameworks, offering services that extend beyond simple compliance to strategic market facilitation. Their unique value propositions include: - Dedicated focus on ANVISA and MAPA regulations, two of the most complex regulatory systems in Latin America. - Real-time regulatory monitoring tools that help clients pre-empt changes and avoid costly delays. - A team composed of former agency personnel and legal experts with insider knowledge of regulatory expectations. ## Financials and Market Positioning While Regularium operates as a private firm and does not disclose public financials, the consultancy is recognized among the top-tier boutique regulatory firms in Brazil for the food and healthcare sectors. The firm's services have become increasingly critical due to: - Over 200 new food product authorizations in Brazil in the past two years requiring professional regulatory support. - Brazil's growing import/export market, with $17.2 billion in food imports (2024), necessitating streamlined regulatory navigation. (Source: ComexStat, ANVISA) ## International Projects and Industry Reach Regularium's clients span both domestic Brazilian startups and international manufacturers entering the LATAM market. They have successfully: - Supported 80+ international food and nutraceutical companies in market authorization processes since 2020. - Advised companies from Europe, North America, and Asia on compliance strategies specific to Brazil. - Delivered over 1,000 hours of corporate training to regulatory teams and professionals across industries. ## Target Market Regularium serves a niche but expanding segment: - Food & beverage manufacturers (both local and foreign) - Nutraceutical and dietary supplement brands - Importers and distributors operating under Brazilian law - Cosmetics and personal care companies looking to comply with ANVISA standards - Legal firms and compliance departments needing regulatory expertise ## Capabilities - Multidisciplinary team including lawyers, pharmacists, and food engineers - Proficiency in Portuguese, English, and Spanish to serve international clientele - Proprietary digital workflows and templates for accelerated dossier preparation - Expertise in handling organic certification, functional foods, and clean label claims ## Certifications and Compliance While consultancy firms are not product-certified, Regularium adheres to internal standards of excellence including: - ISO-aligned document management practices - Ethical conduct aligned with Brazilian Council of Health Regulatory Professionals - Continuous professional development through partnerships with Brazilian food regulation institutions ## Client Testimonials > “Navigating ANVISA regulations was a major bottleneck for our product launch. Regularium made the entire process seamless and predictable.” > — Regulatory Affairs Director, European Nutraceutical Company > “Their team not only understood the legal requirements but also guided us on strategic label claims that improved our product's marketability.” > — Marketing Head, Brazilian Food Startup ## Major Achievements - Successfully helped launch over 100 food products in the Brazilian market between 2020–2024. - Featured speaker at ANVISA compliance forums and regulatory summits in Latin America. - Trusted regulatory partner for several multinational ingredient suppliers entering Brazil. - Developed a proprietary regulatory alert system that monitors daily changes in ANVISA resolutions.