Launch your products with ease
We have agents appointed in several markets to be able to submit marketing applications and/or act as the marketing application holders. RAFINT will help you define your market entry business strategy based on each country regulatory framework.
Marketing authorisation application
We will help you formulate a regulatory strategy that works for you, ensuring that your application is developed and assembled to fit to the standards expected by the country regulatory authority in the región.
Ensure business continuity and keep your peace of mind with post approval maintenance and lifecycle management. Obtaining a marketing approval is just the begining. Our team will help you maintain your product on the región and maximize the valua of your marketing authorisation (MA).
Regulatory, administrative and operational support for the country of authorizations and execution of clinical studies. We can appoint Clinical Research Associates (CRAs) on an AdHoc manner as required.
We can also develop/design low complexity protocols; such as post-Approval Safety Studies (PASS) and descriptive non-interventional studies.
Additional support for your regulatory affairs team and projects: We help you temporally bridge knwoledge or personnel gaps in your country regulatory teams with remote support from our regional Hub.
RAFINT can provide you actionable regulatory intelligence and consultancy for LATAM.