Registering a product can be a hard and longstanding task. It can also involve some investments, because some of them needs testing before applying for registration. If the registration process is not following the correct steps, it can represent a waste of time and money in the future. Imagine that you have a product that is not clearly classified with Brazilian agencies because it can be used for both human and animal applications. You will have to make a decision to apply for ANVISA (Brazilian Health Agency) or MAPA (Animal and Agriculture Related Agency), but still not knowing what the requirements would be, the standards, forbidden or allowed ingredients or substances, or anything about Brazilian law. What is recommended in such case?

Feasibility Study (or Regulatory Feasibility Study) was created to help innovations to come faster into Brazilian market. With a lower investment, your company can know exactly what will be necessary to apply for your product registration in Brazil.

Time Saving

Imagine being one year waiting for a test report (and paying for it) unnecessarily and discovering that if could have been avoided with one simple step that many Regulatory Affairs offices just skip to sell the most expensive services to your company instead of taking the safest path. Innovative products must not have its classification just assumed for a regulatory office. One single mistake can represent a big waste of time and money, producing uncountable damage to your project. Feasibility Study can save much time (as much as an unnecessary document or report can waste), or even worst, you can have your product registered, but, in a wrong category. You think that your product has everything that is needed to be sold and then you discover that it was registered in a wrong way.

What is a Regulatory Feasibility Study, exactly?

It consists of a report that will let you know valorous information, such as:

  • List of necessary documents to apply for registration
  • Required test reports (if applicable)
  • Correct classification regarding the product
  • Forbidden or allowed substances according to the product category (and minimum/maximum amounts of each one)
  • Similar products that were registered
  • Company Licenses required to apply for product registration
  • Claims/advertising that you can not put in the publicity or print/label/package
  • Necessary information for the label/package/IFU to enter into Brazil

Generally, Feasibility Study is delivered 30 days after the application (it is necessary a few more days if your company needs it in any other language different than English). These 30 days can be precious to make sure the regulatory strategy is correct.

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