Definition of strategy and regulatory support for registration and post-registration of products subject to Health Surveillance

Categorization of the product in light of various ANVISA classifications

Feasibility analysis of the product against the Brazilian legislation (Due-Diligence)

Development of Clinical and Regulatory Rationale considering the most effective plan with appropriate costs and timeframes

Assistance for evaluation of the best strategy to prove safety and efficacy of the product, perform clinical trials and elaborate regulatory dossiers

​Elaboration and evaluation of Therapeutic Experimentation Report

Complete elaboration of DCDD [Drug Clinical Development Dossier] or IMDD [Investigational Medical Device Dossier] for innovative products or for those required to prove efficacy and safety for registration

​Request, follow-up and discussions with ANVISA to define the best clinical regulatory strategic plan for the product

Support for registration of the product in other countries (FDA, EMA and other agencies)