Fukuma Advogados & Consultores


  • Product feasibility study – verification of compliance with standards;
  • Drugs’ portfolio analysis;
  • Consulting, advisory services and preparation of the dossiers for product registration before ANVISA (new medicines, similar and generic drugs and biological products);
  • Consulting and advisory services in preparing and formalizing a registration renewal application;
  • Consulting, advisory and preparation of the processes to obtain local license, Federal Authorization and Special Authorization or renewal application;
  • Subscription of the company and the technical responsible at the Professional Council;
  • Consulting and advisory in sanitary infraction notice proceedings and notices linked to quality deviation;
  • Elaboration of administrative defenses;
  • Consulting and advisory in the fulfilment of requirements, and the follow-up of registration and post-registration processes;
  • Audiences scheduling with ANVISA;
  • Assistance in drug recall;
  • Technical and legal consultancy;
  • Consulting and advisory with the Market Regulation Chamber – CMED;
  • Preparation of the international inspection process;
  • Pre-inspection in manufacture plants;
  • Elaboration of Manual of Good Practices;
  • Implementation of Quality System;
  • Assistance for Quality Control Lab implementation.