An Australian company specialized in the development and commercialization of regenerative medicinal products wanted to commercialize its products in Brazil and needed support from a regulatory expert in Brazilian regulations to establish the RA strategy for the product’s registration in Brazil.
Client is a European medical device company that develops and manufactures Antigen Test Kits , was looking for a regulatory professional in Brazil that can act as its local representative in Brazil and register with Anvisa an Antigen rapid test kit used for SARS-CoV-2 Antibody testing.
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 did not have global presence and was seeking a trusted partner to initiate license transfer in Brazil
Case Study 35: Regulatory Strategy, Gap Analysis, Classification and Registration of Cosmetic medical devices in Mexico
The Client is a Canada based manufacturer of iontophoresis-based medical devices machine used to treat excessive sweating of underarms, hands and feet.
The Client is a leading US based manufacturer of visual electrophysiology products used for the diagnosis of retina and optic nerve disease. The products are approved in US as a Class II and III device