Regulatory Affairs

We are regulatory consultants for companies in the healthcare sector with the aim of facilitating access to the Brazilian market.

Product Registration (ANVISA and INMETRO)

Carry out the correct sanitary framework for the product and assist in all stages of the regularization process in both consenting bodies.

Brazilian Registration Holding

Be the holder, technically responsible for the registration of the product in Brazil, representing the manufacturer before the regulatory agency ANVISA.

Pre-Audit Inspection for ANVISA GMPC & INMETRO

Assist and guide the foreign manufacturer in the process of Certification of Good Manufacturing Practices (GMPC), necessary for the regularization of Class III and IV medical devices.