RAFINT assigns a regulatory affairs lead (RAL) which will be the primary point of contact and coordinator of all client regulatory activities in the region.   

 

Our central hub in Lima (Peru), through a partnership, has access to a team of 20 specialists that can be deployed to address urgent regulatory needs.

 

Latin America is a non-harmonized region.  RAFINT exploits non-explicit commonalities among country regulations to repurpose the information and documentations across the target markets.  Having multiple countries centralized with our firm significantly decreases the client overhead.

 

Our in-country agents are carefully selected based on their experience and went through a due diligence process.  They are required to work under RAFINT systems and standards and all regional information is managed within RAFINT document management system.

 

In most countries, our agents have the permits necessary to register regulated products. The requirements to have this legal capacity vary depending on the market, and can range from just appointing an in-country regulatory representative up to having to set a legal entity, have access to a warehouse, appoint a permanent responsible pharmacist, implement a quality system or having a quality control laboratory.