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Five tips to avoid Regulatory Affairs mistakes in Latin America

Atualizado: 12 de dez. de 2019

.  Accept Cross-Culture Differences

Cross culture communication can be a challenge. When doing business in Latin America countries cross-cultural communication is an important key for your success. It is crucial to understand how to communicate effectively with individuals who speak another language and in a different cultural context. Good understanding the differences between your partners is the must. If the company does not understand it from the begging it could be crucial for it success over the sea.


2.   Local Staff

Before hiring your local manager, it is important to get the information in the market. To deal with local regulatory authorities it is very welcome to be represented by your local staff. However, it is very important to see if their activities are in compliance with the regulations in Latin America countries. Sometimes, business jeopardize from that part on. It is specially important to make sure that your local staff are not making advertisements or dealing with authorities without you knowledge. 

3.   No Single Regulattory Affairs Mode.

A company that intends to launch a product in Latin America countries has to realize that a single regulatory affairs model is no achievable. So, a good regulatory strategy must deal with each country separately, considering regulatory peculiarities including language. Therefore, dossiers for product approval process must be prepared in a local language to avoid delays and mistakes.

4.   Product Distribution

In most Latin American countries, a company cannot distribute the product directly from the country of origin without a presence in the country where the product will be sold. Typically, the company must have presence in the country.

5.   Time and Cost

There is no common format and content requirements among Latin American countries. It is important to evaluate the time and cost of the approval process in each country to decide whether it will be better for the company’s business to have its own office in the p

articular country. Time can be crucial to developing the business since the product approval can be longer than expected.

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