The Client is an Asia based global vaccine manufacturer with products marketed in 50+ countries. Client’s management had decided to expand its presence in Latin American countries, with initial focus on Brazil. Client needed a partner with regional presence in Brazil and experience in vaccines or biologics products registration in the country. Considering the business impact of multi-million USD, Client needed a partner that could provide end to end regulatory services.
GRP was identified and retained by the Client as a partner of choice to meet its expansion needs in Latin America, starting with Brazil. GRP, with its local offices in Brazil has helped several biologic, vaccines products registration with ANVISA. Vaccines are registered as biologics in Brazil. GRP performed a thorough assessment of available studies and clinical data on the products, (the products were not registered in USA or Europe) and drafted an optimum regulatory strategy for their registration in Brazil.
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