Vita Regulatory Affairs Consulting
Vita Regulatory Affairs Consulting is a company specialized in technical and regulatory affairs, providing support to its clients in order to offer the necessary solutions to achieve the maximum quality of services provided. Based in Brazil and Portugal, our team is formed by experienced professionals in Latin America, especially in Brazil (ANVISA), as well as in the European Union (Infarmed, EMA and EDQM).
Preparation and submission of dossier in e-CTD format
Instruction, conversion, or preparation of dossier in e-CTD format, including internal training and provision of templates.
Audit of compliance regulatory framework for managing changes in products and processes in light of current legislation.
ANVISA – List of Active Substances for Periodic Benefit-Risk Evaluation Reports (updated on December 20th, 2021)
On December 13th, 2021, ANVISA published the list of Periodic Benefit-Risk Assessment Reports (RPBR)Read more
ANVISA – Deadline extension for the implementation of packaging process online control and 100% integrity test
After some deliberations between the regulated sector and the regulatory authority, on DRead more
ANVISA – Guideline on Remote Inspections
On November 25th, 2021, Anvisa published Guideline No. 54/2021 (version 1) on Remote Inspections.Read more
I learnt about Vita Consulting back in 2019 when I needed some regulatory intelligence on Latin America. I explained my request to them, and they did a fantastic job in delivering the accurate information, within the timeframe and on budget. After considerable time had passed, I required some clarifications and extra support on another angle of my project and Vita Consulting did not disappoint. In fact, they went over and above to help me and were so efficient at it. If I require further work in Latin America, I will definitely use them and highly recommend them to anyone considering their services.