SERVICES

At Register Medical Group, we understand the complexity of regulatory processes in Brazil and international markets. Our mission is to provide comprehensive and strategic support for the regulation of pharmaceuticals, medical devices, cosmetics and household sanitizers, ensuring that companies always comply with ANVISA and other regulatory agencies standards and regulations.

Register Medical Group offers specialized consulting for product registration with ANVISA, tailored to each client’s needs. Our team of experts supports every step of the process, from the initial analysis to the publication of the registration, including:

✔ Product classification based on ANVISA’s regulatory framework.
✔ Feasibility analysis for product registration, considering its specific characteristics and regulatory requirements.
✔ Dossier preparation and submission, including technical documentation, efficacy and safety studies, risk management, biocompatibility, and other required reports.
✔ Registration process monitoring with ANVISA, including electronic petitions, protocol submission, and follow-ups until publication in the Official Gazette (D.O.U.).
✔ Labeling and package insert compliance consulting according to ANVISA and international regulatory guidelines, ensuring clarity and adherence to regulations.
✔ Support in obtaining import and export authorizations, with a focus on the specific regulations for each product.

With our consulting services, your company will receive the necessary support to expedite the registration process and ensure compliance with ANVISA and international regulatory standards.