Services

Our Services

EPC has a wide range of services to be provided to your company, in this important and strategic segment of Regulatory Affairs in Sanitary Surveillance. It has more than 30 years of experience, challenges and achievements.

Consulting for Business Operation Authorizations - AFE/ANVISA

  • Obtaining of Authorizations for the Operation of Companies – AFE/ANVISA, for manufacturers, importers, exporters, warehouses, distributors and carriers of divers types of products.

Consulting for Certifications of Good Manufacturing, Storage and Distribution Practices – ANVISA

  • Elaboration, protocol and procedural follow-up.
  • Interaction with manufacturers, audits and in-loco inspections.

Consulting in Obtaining of the Registers at ANVISA.

  • Medical equipment
  • Materials for Use in Health
  • Orthopedic Implants
  • In Vitro Diagnostic Products (IVD)
  • Sanitizing
  • Cosmetics
  • Analysis, classification and product framing
  • Elaboration of processes to obtain registration
  • Process follow-up

Technovigilance - ANVISA

  • Service and support in Notifications
  • Training

Sanitary Law

  • Administrative appeals against dismissal of proceedings
  • Injunctions/Warrants
  • Legal procedures for procedural speed
  • Opinions
  • Formal consultations with ANVISA
  • Specialized Legal Advice in Sanitary Law

INMETRO Certifications and Authorizations

  • Certifications and Authorizations of Models of medical products with INMETRO (Brazilian Certification Body) and other pertinent organizations.

Presential Protocols and/or withdrawals of processes/documents

  • Registration of documents with ANVISA and other pertinent organizations.

  • Withdrawal of processes / documents from ANVISA and other pertinent organizations.

  • Protocols and withdrawals of various documents in the other agencies located in Brasilia.

Legalization, Consularization or Document Placement

  • Ministry of Foreign Affairs/Itamaraty, Foreign Embassies and others.

Quality Manual

Quality Manual elaboration in conformity with requirements of the following legislations:

  • RDC No. 665, March 30th, 2022;