Commercial distribution of pharmaceutical products to hospitals, clinics and institutional tenders — with licensed regulatory pharmacist, sanitary registration and regulatory affairs integrated under a single local partner.
Saluvexis is the pharmaceutical and medicines distributor for international laboratories commercializing in Costa Rica and Central America. Unlike traditional regulatory consultants, Saluvexis executes the entire commercial pharmaceutical chain: we manage sanitary registration before the Ministry of Health through the Regístrelo platform, maintain the licensed regulatory pharmacist, participate in tenders of the Costa Rican Social Security Fund (CCSS) and supply private hospitals and clinics.
Operation aligned with international standards: FDA, EMA, GMP and ISO. Costa Rican SME certified by MEIC, with licensed regulatory pharmacist registered with the Costa Rican College of Pharmacists and active sanitary operating license from the Ministry of Health.
The laboratory obtains complete commercial access to the Costa Rican market under a single contract and a single local point of contact.
Certificate issued by the Ministry of Health, valid for five years, enabling import and commercialization of the medicine in Costa Rica.
Saluvexis licensed regulatory pharmacist in charge of legal and technical compliance of the pharmaceutical operation.
Active participation in institutional procurement of the Costa Rican Social Security Fund through Saluvexis as a qualified SICOP supplier.
Continuous distribution to private hospitals, clinics and pharmacies in Costa Rica with reliable logistics and documented traceability.
Compliance with the National Pharmacovigilance System, adverse event management and periodic reports to the manufacturer.
One single local partner responsible for the entire pharmaceutical chain: regulatory, import, distribution, pharmacovigilance and commercial support.
Pharmaceutical regulatory consultants (Freyr, Pharma Wizard, Emergo, MDRC) only handle paperwork. They deliver the sanitary registration certificate and disconnect. Saluvexis does the opposite: once the medicine is registered, the real commercial work begins. And because we have a licensed regulatory pharmacist on staff, there's no need to hire independent professionals.
| Capability | Regulatory Consultants | Saluvexis |
|---|---|---|
| Pharmaceutical sanitary registration | ✓ | ✓ |
| In-country registration holder | ✓ | ✓ |
| Licensed regulatory pharmacist included | Partial | ✓ Integrated |
| Active commercial distribution | ✗ | ✓ |
| Participation in CCSS tenders | ✗ | ✓ |
| Supply to private hospitals and pharmacies | ✗ | ✓ |
| Operational post-sale pharmacovigilance | ✗ | ✓ |
| One single contract and contact | ✗ | ✓ |
Saluvexis doesn't just register your medicine — we also distribute it. One single local partner. One single contract. One single point of contact for the entire Costa Rican market.
Yes. Saluvexis is an active supplier in SICOP and participates in pharmaceutical tenders of the CCSS and other public entities, in addition to supplying medicines to private hospitals and clinics in Costa Rica.
Decree 43590-S, in force since December 2022, establishes the recognition by homologation of sanitary registration for medicines already approved by member authorities of the International Council for Harmonisation (ICH): FDA, EMA, PMDA (Japan), Health Canada, Swissmedic, ANVISA, COFEPRIS, MFDS (Korea), NMPA (China), HSA (Singapore), SFDA (Saudi Arabia), TFDA (Taiwan) and TITCK (Turkey). This significantly accelerates the process for medicines already approved by these agencies.
Yes. Costa Rican regulations require any company commercializing medicines to have a licensed regulatory pharmacist registered with the Costa Rican College of Pharmacists. Saluvexis has an active licensed regulatory pharmacist, so the laboratory doesn't need to hire an external one.
Pharmaceutical sanitary registration issued by the Ministry of Health is valid for five years and is renewable. Saluvexis handles renewals and post-registration modifications throughout the product lifecycle.
Regístrelo is the digital platform of the Costa Rican Ministry of Health for managing sanitary registrations of medicines, pharmaceutical products and other regulated products. All documentation and procedures are managed through this platform, which Saluvexis handles as part of the integrated service.
Yes. Saluvexis represents 15 international manufacturers and distributes generics, innovators, biosimilars, biologics and specialty medicines, all from manufacturers aligned with FDA, EMA, GMP and ISO standards.
Bioequivalence studies are required for generic medicines according to Decree 32470-S and related regulations of the Ministry of Health. There are also exemptions (bioexemption) for certain products based on technical criteria. Saluvexis advises the laboratory on specific requirements for each product.
Yes. Saluvexis complies with the National Pharmacovigilance System: monitors adverse events, manages reports to the Ministry of Health and the manufacturer laboratory, and maintains required records throughout the entire product lifecycle.
Active distribution of class I-IV devices with integrated sanitary registration.
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Specialized formulas for hospitals: renal, hepatic, immune support.
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Active participation in SICOP tenders for the Costa Rican Social Security Fund.
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Direct supply to CIMA, Metropolitano, Clínica Bíblica and Hospital La Católica.
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Integrated entry to the Costa Rican market under a single local contract.
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Complete file management under Decree 34482-S.
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