ANVISA

Company Registration

  • Company Registration;
  • Security Manager Registration;
  • Registration of Legal Responsible;
  • Registration of Technical Responsible;
  • Recovery or Password Change – Individuals;
  • Recovery or Password Change – Legal Entity;
  • Gate update.

AFE - Operating authorization

  • Granting of Company Operation Authorization (AFE) for Medicines, Pharmaceutical Inputs, Health Products (related), Sanitizing Products, Food, Cosmetics, Perfumes and Hygiene Products;
  • Granting of Special Operation Authorization (AE) for Medicines and Pharmaceutical Inputs;
  • Granting of Good Distribution and Storage Practices Certification (CBPDA);
  • Granting of Good Manufacturing Practices Certification (CBPF);
  • Change in the Company’s Operating Permit (AFE/AE): Address, Corporate Name, Legal Responsible, Technical Responsible, Security Manager;
  • Expansion or Reduction of Activities; Expansion or Reduction of Classes;
  • Company Operating Authorization Certificate (AFE and AE);
  • Concession of Product Export Certificate;
  • Electronic application;
  • Process Monitoring;
  • Acompanhamento do Diário Oficial da União – DOU;
  • Compliance with Requirement.

Regularization of Products in all segments subject to regulation at ANVISA

Registration, Alterations, modifications, rectifications, product inclusions in the regulatory Agency in the segments of:

  • Health products;
  • Cosmetics and personal care;
  • Medicines;
  • sanitizing agents;
  • Foods;
  • Elaboration of content for product labels and packaging.

Regulation regarding import

  • Announcement on Start of Import/Manufacture of Food;

Audits for Implementation / Adaptation or Periodic purposes. All focusing on the requirements described in the health legislation in force

The first or second part audits will be carried out in your company by qualified and trained professionals from Max Consultoria Regulatória. At the end of each audit, we will be presenting the report containing each item checked during the audit to the company’s Senior Management.

Available audit methods:

  • Audits may be carried out in Industries, Importers, Distributors, Health Services and other establishments subject to regulation by the special Autarchy (Anvisa).

Audits for Implementation / Adaptation or Periodic purposes. All focusing on the requirements described in the health legislation in force

  • Rectification of Publication in the Federal Official Gazette – DOU;
  • Apostille Service and Recognition of Firms;
  • Protocol Service and Withdrawal of Documents in Brasília/DF (Except those that are already in virtual format implemented by the special Autarchy)
    Transfer of Ownership of Product Registration.
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