MedWisdom LifeScience Company is dedicated to supporting life sciences companies in their journey from local to global markets. With a profound understanding of regulatory landscapes across 120+ countries, we specialize in delivering comprehensive solutions and services.
In Brazil, ANVISA serves as the regulatory authority under the Health Ministry, overseeing the registration of drugs, medical devices, food supplements, and cosmetic products. Compliance with ANVISA regulations is essential for market entry and product success. At MedWisdom, we offer end-to-end regulatory services designed to facilitate your regulatory journey. Our expertise spans regulatory strategy development, market intelligence, and local representation. We specialize in post-approval product maintenance to ensure compliance and market access.
Medwisdom Lifescience Offerings in Brazil
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Pharmaceuticals |
Medical Devices |
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ANVISA Drug Registration |
ANVISA Medical Device Registration |
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Clinical Trial Applications |
Clinical Evaluation and Performance Studies |
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Drug Master File (DMF) Submissions |
Quality Management System (QMS) Audits |
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Bioequivalence and Bioavailability Studies |
Risk Management and ISO 13485 Compliance |
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GMP Compliance |
Technical File Preparation and Submission |
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Pharmacovigilance and Drug Safety |
Post-Market Surveillance and Vigilance |
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Advertising and Promotion Review |
Labelling and Instructions for Use Compliance |
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Drug Labelling and Packaging Compliance |
Importation and Exportation Permits |
Fees: https://www.gov.br/anvisa/pt-br/english/regulation-of-products/drugs