We are an innovative firm that provides comprehensive regulatory affairs solutions for the Latin America region serving the biotechnology, pharmaceutical and medical device industries. Our services cover the clinical, 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 or activity. Our senior team has an average of 10+ years of experience on pharmaceuticals and biologics, medical devices and cosmetics. We have a network of in-country regulatory personnel in Colombia, Ecuador, Peru, Chile, Argentina, Paraguay, Mexico and Central America and the main Caribbean countries, we also have a central hub in Lima (Peru) that, through a partnership, has access to a team of 20 specialists that can be deployed to address urgent regulatory needs. This flexible system allows RAFINT to achieve the perfect balance between high-quality and cost-efficient work for the region. Our focus is the under-served "small markets" in the region were high quality, safety and effective products have a significant lag on regulatory submission and approval. RAFINT has set-up agents located in Ecuador, Peru, Chile, Colombia and Central America that can register the products directly and, in some countries, also hold the marketing approvals for our clients (as required per country regulations), facilitating market access and separating the commercial and regulatory functions. We understand that different clients and products have different needs, so we have developed a special service package for products with low commercial volume but high medical value, such as orphan drugs, and a package for clients with very few products but that provide a breakthrough on the treatment of serious or life threatening disease. We can discuss your company needs and the solutions we can provide. Contact us to set up a call at: information@rafint.com