Taking the Brazil pill: challenges and opportunities

Brazil has surpassed 200 million residents. B2B healthcare network Medicamatch.com says that having a product approved for commercialisation in the country could result in fast exponential growth for pharmaceutical companies.

However, to introduce any new product in Brazil it's necessary to register it and get the approval of ANVISA (National Agency for Sanitary Control). Currently, the organisation manages too many healthcare issues, so the process for foreign companies of any size is time and money consuming without the proper knowledge of the process, language and idiosyncrasy of the Brazilian public sector.

According to the Brazilian Research and Development Institute of Pharmaceuticals, the approval of a given product can take on average more than 15 months, even if previously approved in other countries by agencies like the FDA. Companies trying to introduce a new product can have a difficulties in learning the right way to register, losing time and money in the process.

Counseling companies overview every point including market and distribution studies, authorisation to carry out a preliminary analysis, audit and identification of required certifications, determination of fees for necessary registration or notifications, monitoring and securing a business environment and the procedures for registration, that include filing and following up with relevant agencies.

One of the firms advocated to assisting new game players include Mandala International and their Brazilian branch, which in a recent interview the chairman Stephan Fontanel commented that “most of our companies that come seek our services are companies that tried to register a product in Brazil by themselves and realized it is far from being a peaceful walk at the park”.