Case Study 121: Regulatory Strategy for Class IV Regenerative Medical Device in Brazil
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.
Case Study 71: Registration of Covid-19 Test Kit 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.
Case Study 63: Registration of Vaccines with Anvisa in Brazil
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.
Case Study 59: Marketing Authorization License Transfer in Brazil for Biologic New Drug
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.
Case Study 36: Regulatory Support for Visual Electrodiagnostic Testing System in Mexico and Brazil
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