Passarini Regulatory Affairs offers a range of regulatory services, in addition to practical solutions to overcome the regulatory barrier in countries like Brazil, Argentina, Colombia, Mexico, Peru, the USA, and the European Community.
It is located in Ribeirão Preto (SP) and serves the entire national territory. It has a commercial office in São Paulo capital, besides an office in Joinville (SC) to act in the international market and an office in Miami (FL) for exclusive service to the FDA.
The company was born in 2009, and it counts on more than 15 years of experience from its founder, Paulo Passarini, who is a health technologist and postgraduate in quality, that served directly at the Comitês Brasileiros de Normas Técnicas. He worked in big companies before he founded his own company, which today is a partner business.
The employee’s team is a highly qualified professional with over ten years of experience in the health regulation area.
Personalized service to its customers, always valuing transparency, respect for the company’s culture, in addition to trust and agility, which have always been a part of the culture and work path of Passarini Regulatory Affairs.
The company has technical and legal knowledge equalized to the correct interpretation of the norms and legal requirements. In addition to preparing specific opinions about the correct interpretation of the health standards to act at ANVISA, INMETRO, ANATEL, FDA (510k), Marcação CE, INVIMA, ANMAT, COFEPRIS, and DIGIMED.
Besides the possibility to use the hosting service in those countries and mostly the ease of being a European representative in Portugal.
For the systems implantation and maintenance of the ISO 9001, ISO 13485, and Boas Práticas de Fabricação – BPF (ANVISA) services.
In the established schedule, you can see the company’s culture to implement work that involves the employees responsible for the subject matter.