Kivalita assists companies that seek to market their finished products or APIs in Brazil, facilitating business with Anvisa and adapting processes to Brazilian GPx.
We have a multidisciplinary and bilingual team, made up of international auditors, regulatory affairs experts and quality managers.
RDC 658 March 2022 – Good Manufacturing Practices for Pharmaceuticals.
RDC 362 March 2020 - Criteria for certification of Good Manufacturing Practices and institutes the inspection program for international establishments manufacturers of active pharmaceutical ingredients.
RDC 166 July 2017 - Validation of Analytical Methods