Pharmaceutical and Pharmachemical Industry

The pharmaceutical and pharmachemical sector in Brazil is strategic and of great economic relevance, being rigorously regulated by ANVISA. Our practice includes importers, manufacturers, distributors, suppliers of inputs, and transport companies, encompassing:

• Regulatory Compliance: Guidance on ANVISA regulations and other competent authorities. Assistance in the regularization of medicines and pharmaceutical inputs, including Good Manufacturing Practices (GMP), licensing, etc.
• Complex Contracts: Drafting and reviewing clinical research contracts, commercial contracts, outsourcing manufacturing stages, distribution contracts, technology transfer agreements, PDPs, among others.
• Litigation and Disputes: Representation in judicial and administrative disputes, including arbitration as an efficient alternative for conflict resolution in the pharmaceutical sector, including procedures before CONAR and INTERFARMA, as well as conducting civil inquiries and negotiating agreements with the Public Prosecutor’s Office, for example.
• Sanitary Infractions: Defense, appeals, and monitoring of sanitary infraction processes at the federal, state, and/or municipal levels.
• Company Licensing: Assistance in obtaining the Authorization for Company Operation (AFE) from ANVISA, as well as Special Authorization (AE) and local sanitary licensing.
• Import and Export Consultancy: Assistance in the import processes of medicines and pharmaceutical inputs. Coordination with foreign offices in projects for the internationalization of Brazilian companies.
• Price Regulation and Extraordinary Price Adjustment Requests: Representation before the Drug Market Regulation Chamber (CMED) to ensure compliance with drug price regulation standards. Assistance in the preparation and submission of extraordinary price adjustment requests, as well as administrative defenses for price regulation infractions.