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  • 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)

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