Specialized service for registration of interchangeable generic medicines with bioequivalence studies (BE), comparative dissolution profiles (CDP), and application of the official reference product framework from the Ministry of Health.
In recent decades, the quality, safety, and efficacy standards of medicines have evolved significantly. Bioequivalence is the regulatory basis that allows Costa Rica to guarantee interchangeable generic products with scientific support.
Since 2000, Costa Rica has updated its regulatory framework for medicine registration, Good Manufacturing Practices, Good Laboratory Practices, Stability Studies, and Validation of Analytical Methods — necessary foundations for applying bioequivalence criteria.
Today, bioequivalents registration in Costa Rica requires alignment with:
Saluvexis verifies that the reference product is correctly identified in the current LAMR published by the Ministry of Health before initiating any study or registration procedure.
Confirmation of reference product in current LAMR
Definition of bioequivalence studies or dissolution profiles
Bioequivalence Study Report Form
Procedure before the Ministry of Health and technical inquiries
Let's discuss the most efficient strategy for your case.
Regulatory strategy for products requiring bioequivalence or in vivo exemption.
