We are an innovative regulatory affairs service star-up firm, founded in 2016 in Peru by a regulatory manager with global regulatory experience whom partnered with the head of the largest Peruvian regulatory affair consulting firm.
We serve primarily the biotechnology, pharmaceutical, medical device and cosmetic industries but we have successfully handled regulatory projects for other product types. Our services cover the development, approval and post-approval phases of the product life-cycle and range in scope from the full regulatory management of the LATAM region to operational support for a specific project, country or activity.
Our operational model allows us to provide a high quality regional regulatory affairs service par to that of a mature global company at a very competitive cost.
We execute our services through a network of specialized country agents that are required to use RAFIT document management system and RIMS platform allowing us to work as a single regional team.
In several markets our agents have the legal capacity to directly submit marketing applications and/or act as the country marketing application holders for our clients.