MANDALA INTERNATIONAL and JOMDD have signed a partnership agreement.
MANDALA INTERNATIONAL has been a regulatory affairs specialist for Brazil, Mexico, and Colombia for the past 15 years. Mandala have organizations in Brazil and Mexico with their own Technical Department and Pharmacist. MANDALA has all the Authorization Licenses by ANVISA and COFEPRIS to register pharmaceuticals, cosmetics, medical devices, food supplement, and sanitary products.
1. Company Regulation in Brazil and Mexico
Company Operating Authorization (AFE for Manufacture, Importation, Distribution, Storage…)
Composition of Quality Management processes
2. Regulatory Services
Regulatory Affairs and Quality Assurance
Product registration with ANVISA/MAPA/COFEPRIS/INVIMA/EU(soon)
Pre-audit Inspection : GMP & Regulatory Due Diligence
Certificate: INMETRO and ANATEL for Brazil
3. Business Management
Distributors and Partners Research
Back office Management for subsidiary: Administration/ Finance
We are actively accepting consultations regarding regulatory affairs and sales of medical devices in the United States, Europe, the Middle East, and South America. Please feel free to contact us. (Contact: firstname.lastname@example.org)
Location：1 Place de la Libération, 73000 Chambéry – FRANCE