Specialized service for registration and control of biological medicines: vaccines, biosimilars, blood derivatives, recombinant DNA products, monoclonal antibodies, and gene/cell therapy under Technical Regulation RTCR 440:2010 (Decree 37006-S).
Registration of biological medicines requires differentiated technical expertise due to their complexity and specific requirements for risk management plans and post-marketing pharmacovigilance.
The registration of biologics in Costa Rica has its own framework due to the technical complexity of these products. Saluvexis applies the specific regulation and complementary Central American regulations.
Biologics registration requires specialized expertise in risk management plans, post-marketing pharmacovigilance, and technical characterization. Saluvexis accompanies the complete process.
Characterization and classification under RTCR 440:2010
Compilation with focus on quality, safety, and efficacy
Post-marketing pharmacovigilance strategy
Renewals, ongoing pharmacovigilance, modifications
Let's discuss the specific quality, safety, and efficacy requirements.
Specialized expertise in risk management plans and post-marketing pharmacovigilance.
