The updating of ANVISA’s regulatory framework for clinical research represents a strategic opportunity for companies wishing to boost drug development in Brazil. The reduction in bureaucracy and the possibility of anticipating the import of drugs for research are advances that not only speed up studies, but also bring predictability and efficiency to sponsors and research centers.
At ELS, we are prepared to help our clients take full advantage of these changes. Our ELSApdi service is designed to facilitate everything from the submission of ongoing data to ANVISA to the management of clinical trial import and monitoring processes, ensuring agility and compliance with the new regulatory standards.
With clearer definitions of risk categories and study phases, ANVISA’s modernization strengthens Brazil’s competitiveness on the global stage. This creates a favorable environment for integrating the conduct of clinical research with obtaining international certifications, such as EU GMP, increasing the relevance of Brazilian products in foreign markets. At ELS, we see this evolution as an opportunity to consolidate strategic partnerships and offer solutions that add value at all stages of clinical and regulatory development.
If you need more information on regulatory issues, ELS can certainly help.
ontact your local ELS consultant or via email info@elssolutions.pt
