Regulatory Services

Licensed Regulatory Pharmacist in Costa Rica

Licensed regulatory pharmacist service for companies that import, store, distribute or commercialize medicines in Costa Rica. Mandatory requirement of the College of Pharmacists.

Regulatory Pharmacist Saluvexis Costa Rica
Service detail

What is the regulatory pharmacist and why is it mandatory?

Costa Rican regulations require any company that imports, stores, distributes or commercializes medicines to have a licensed regulatory pharmacist registered with the Costa Rican College of Pharmacists. This professional is responsible for the technical-pharmaceutical compliance of the operation and represents the company before sanitary authorities in pharmaceutical matters.

Functions of the regulatory pharmacist

  • Technical-pharmaceutical compliance: verification of the quality and authenticity of medicines handled.
  • Good Distribution Practices (GDP): ensuring compliance with pharmaceutical GDPs.
  • Pharmacovigilance: operation of the National Pharmacovigilance System.
  • Controlled medicines: management and reporting of psychotropics, narcotics and precursors per regulations.
  • Representation before the College: compliance with College of Pharmacists requirements.
  • Representation before the Ministry of Health: in technical-pharmaceutical matters of the operation.
Results

What does the company obtain?

Concrete results for your regulatory operations in Costa Rica.

Active licensed pharmacist

Professional registered and current with the Costa Rican College of Pharmacists.

Legal compliance

Mandatory requirement covered without hiring a dedicated professional.

Good Distribution Practices

Pharmaceutical operation in accordance with current GDPs.

Pharmacovigilance

Operational system and reports to the Ministry of Health.

Controlled medicines

Management in accordance with psychotropics and narcotics regulations.

Flexible model

Service integrated with distribution or independently for small companies.

Differentiator

Why Saluvexis for regulatory pharmacist?

Many small or new companies have difficulty hiring a full-time regulatory pharmacist. Saluvexis has an internal licensed pharmacist and can offer this service under flexible modalities, per the terms defined by the Costa Rican College of Pharmacists.

Saluvexis covers the regulatory pharmacist requirement without the company having to hire a dedicated one. Legal compliance with the advantage of a partner who can also distribute and register your products.

FAQ

Your most common questions

Who needs a regulatory pharmacist in Costa Rica?

Any company that imports, stores, distributes or commercializes medicines in Costa Rica must have a licensed regulatory pharmacist registered with the College of Pharmacists. This applies to drug warehouses, distributors, pharmacies and medicine representatives.

Does Saluvexis offer regulatory pharmacist as a standalone service?

Yes. Saluvexis's licensed regulatory pharmacist can act as pharmacist for third-party companies under terms defined by the College of Pharmacists. This allows small or new companies to meet the requirement without hiring a dedicated professional.

What functions does the regulatory pharmacist perform?

The regulatory pharmacist is responsible for the technical-pharmaceutical compliance of the operation: product verification, Good Distribution Practices compliance, pharmacovigilance, controlled medicine management and compliance before the College of Pharmacists and Ministry of Health.

Does the service also include pharmacovigilance?

Yes. The Saluvexis pharmacist operates the National Pharmacovigilance System for products under their responsibility, including adverse event reports to the Ministry of Health and the manufacturer.

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What is your specific need?

Let's discuss how Saluvexis can support your entry or expansion in Costa Rica.