Comprehensive management of sanitary registrations before the Ministry of Health for pharmaceuticals, medical devices, cosmetics, supplements, biologics, bioequivalents, natural products, homeopathics, and medicinal cannabis. Plus legal representation and licensed regulatory pharmacy.
Products with established regulatory frameworks in the Costa Rican health sector: medical devices, pharmaceuticals, foods and supplements, cosmetics, and natural medicinal products.
Devices
Complete file management under Decree 34482-S with Health Canada classification and simplified pathway for products with FDA, EMA or PMDA approval.
Pharmaceuticals
Management via Regístrelo platform under RTCA Medicine Registration and Decree 43259-COMEX-S-MEIC for chemical synthesis and pharmaceutical specialties.
Food
Sanitary registration of processed foods, dietary supplements, infant formulas, and raw materials under RTCR 436:2009 and RTCA 67.01.31:20.
Cosmetics
Notification, importation, and registration of cosmetic products under Resolution 474-2023 (COMIECO-EX) and the new Cosmetics Registration Regulation.
Natural
Registration, renewal, and mutual recognition of natural medicinal products for human use under RTCA 11.03.64:19.
Products with specific regulations requiring differentiated technical expertise: biologics, bioequivalents, and medicinal cannabis. Saluvexis has developed deep knowledge in each of these regulatory frameworks.
Biologics
Registration and control of biological medicines: vaccines, blood derivatives, biosimilars, recombinant DNA, monoclonal antibodies, and gene/cell therapy.
Bioequivalents
Registration of interchangeable generic medicines with bioequivalence studies, comparative dissolution profiles, and application of the official reference product framework.
Medicinal Cannabis
Registration of cannabis-based medicinal products under Decree 44917-S (RTCR 515:2024). Saluvexis is one of the few local partners with expertise in this emerging niche.
Therapeutic categories with regulations distinct from conventional medicines. They require specific knowledge of applicable regulations and specialized procedures.
Costa Rican regulation requires specific local figures to operate medical-pharmaceutical products. Saluvexis fulfills all these functions with qualified internal staff.
Representation
Saluvexis acts as the local figure before the Ministry of Health while keeping ownership of the registration with the manufacturer. We don't keep your registration — we represent it.
Pharmacy
Active in-house licensed regulatory pharmacist before the Costa Rican College of Pharmacists — legal requirement to operate pharmaceutical products in the country.
Compliance
Ongoing post-approval registration maintenance: renewals, modifications, pharmacovigilance reports, response to inquiries, and sanitary audits.
This is a fundamental distinction that sets us apart from many competitors: Saluvexis does not keep your sanitary registration — we represent it.
The sanitary registration is the manufacturer's property. Saluvexis acts as local Legal Regulatory Representative, managing the procedure, maintaining ongoing compliance, and being the point of contact before the Ministry of Health, without appropriating the regulatory asset.
This means that if in the future the manufacturer decides to change local partners, the registration stays with them — a fundamental ethical and commercial guarantee.
12 specialized services to accompany manufacturers at every stage of the regulatory cycle.
