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Pharma Regulatory Services in Costa Rica - Overview
Costa Rica mandates marketing approval before manufacturing, importing, or selling medicines, requiring evidence of quality, safety, and efficacy consistent with regional practices in Latin America. Regional harmonization via The Pan American Network for Drug Regulatory Harmonization (PANDRH) promotes guideline alignment, good Regulatory practices, and reliance approaches for Costa Rica to streamline assessments. Emerging multi-country collaborations, such as the Latin American and Caribbean Medicines Agency (AMLAC), demonstrate growing Regulatory science convergence across Latin America, thereby enhancing sponsor predictability.
Reliance options and regional convergence enable faster, lower-risk product approvals by reducing duplication and streamlining the approval process. PANDRH’s good practices and competency development improve consistency, clarity, and predictability in requirements and reviews. Multi-country initiatives like AMLAC expand opportunities for sponsors' submissions and lifecycle planning across Costa Rica and similar regions.
Freyr Expertise
- Regulatory strategy involving selecting a pathway (innovator, generic, biosimilar) with evidence mapping to local and regional standards
- CTD-aligned dossier development, gap analysis, and assembly for national filings, ensuring Spanish-language readiness
- Support in drafting administrative documents, coordinating legalization/apostille, and providing notarized Spanish translations to prevent administrative holds
- Bioequivalence and comparability assessments
- Labeling and promotional material compliance: Spanish label/leaflet content, claims review, and artwork controls aligned to regional standards.
- Pharmacovigilance Facility Setup: local safety workflows, ICSR submissions, and risk management planning consistent with regional PV frameworks.
- Post-approval submissions and lifecycle management
- Freyr manages variations, safety updates, labeling changes, product and site transfers, and renewals with precise classification and data-mapping to authority expectations.