The registration process involves preparing and submitting detailed documentation, including safety and efficacy data, to regulatory authorities. We ensure compliance with local regulations and manage communications with the authorities to secure approvals.
The duration varies by country and product type but typically ranges from several months to over a year. Our team works diligently to expedite the process and keep you informed of progress.
Required documentation includes technical specifications, clinical trial data, manufacturing information, labeling details, and quality assurance protocols. We assist in compiling and reviewing all necessary documents to ensure completeness and accuracy.
Yes, we provide support for international registrations in every country in Latin America and the Caribbean, navigating the regulatory requirements of different countries to help your medical products reach global markets efficiently and compliantly.