Why choose a regulatory affairs company?November 25, 2019
Do you know why choosing a regulatory affairs company in Brazil?
In order for a company to be able to commercialize products in Brazil, it is necessary to regulate it in the responsible bodies, such as the National Health Surveillance Agency (ANVISA) and or the Ministry of Agriculture (MAPA).
A consultancy specialized in regulatory affairs assists in the regularization of companies and products. See more below.
What are regulatory affairs?
First of all, let’s understand better what regulatory affairs are.
In order for a manufacturer, importer or trader to be able to sell his products in Brazil he must have his company registered as well as his products.
Foreign companies can only operate
in Brazil marketing their product, if they have a link in the country.
How is the process of regulation?
It is understood that every company that is interested in manufacturing, importing or marketing products in Brazil must first be legalized.
After regularization of the company, it is necessary to perform the registration, registration or notification that varies according to each product and responsible body. Only after the approval of the registration process is published in the Federal Official Gazette, the holder company will be authorized to manufacture, import or market the product of interest.
The process can be very simple and safe when the person seeking advice that can assist him and perform the whole process with the body responsible.
The bodies responsible for certification or registration are:
MAPA – Ministry of Agriculture, Livestock and Supply
MAPA is the agency responsible for activities involving agricultural goods and services, and registration is mandatory in accordance with the rules and requirements of the agency itself.
INMETRO – National Institute of Metrology, Quality and Technology
INMETRO is a federal institute acting in industrial quality aiming at the quality and safety of products and services.
ANVISA – National Health Surveillance Agency
ANVISA aims to oversee and promote protection in relation to health, sanitary control and the consumption of products and services.
ANATEL – National Telecommunications Agency
The National Telecommunications Agency (ANATEL) is the national agency responsible for the regulation and approval of products used in telecommunications, respecting the quality and safety requirements.
What is a regulatory affairs consultancy?
A consulting company that works in the regulatory affairs area takes care of the whole process for the regularization of products and services.
It is the responsibility of the company to be able to perform all services related to regularization, acting with transparency so that the customer is aware of the entire process.
A regulatory consultancy and advisory firm can provide healthcare, agriculture, automotive, pharmaceutical, cosmetics, food, household and other products. Each product responds to a type of process according to its responsible agency.
Licempre is a company specialized in regulatory matters such as company registration and product registration with ANVISA, INMETRO, MAPA, Anatel and hosting product registration for foreign companies interested in bringing their products to Brazil.
What are the advantages of hiring a consultancy?
There are many advantages to choosing a regulatory advisory firm. We can highlight the agility, expert knowledge, practicality and security to take care of the whole process.
In addition, the bureaucracy is less when hiring specialists who are able to assist in all stages bringing more agility to the interested.
Finally, we can conclude that hiring a company that specializes in regulatory affairs in Brazil, brings many benefits to those who hire.
You can learn more about this or clarify your doubts by speaking with one of our experts.