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Pharma Regulatory Services in the Dominican Republic - Overview
The Dominican Republic regulates medicinal products through the Ministry of Public Health, via the national medicines authority, which requires product registration before manufacturing, importing, distributing, or marketing. The framework stresses evidence of quality, safety, and efficacy, Spanish-language documentation, legalized certificates (e.g., CPP, GMP), and recognized GMP for foreign facilities.
Why choose Freyr
Freyr blends Spanish-language skills, regional Regulatory expertise, and global quality systems to ensure fully first time right submissions. Building on our Local RA expertise, we can integrates administrative processes—such as legalization, notarization, apostille, and certified translation—with early certificate planning into project timelines to minimize delays in the process. Proactive engagement with authorities and evidence-based responses effectively close queries and keep projects on schedule.
Freyr Expertise
- Regulatory strategy: Pathway and reliance positioning tailored to the Dominican Republic.
- Dossier authoring: CTD-aligned modules and country forms prepared in Spanish.
- Administrative documentation: CPP/GMP planning, notarization, apostille, and certified translations.
- Bioequivalence and comparability: applicability checks, protocol outlines, and biowaiver rationale.
- CMC and GMP: stability, specifications, validation mapping, and foreign‑site GMP evidence.
- Labeling compliance: Spanish labels/leaflets, mock-ups, and claims review per national norms.
- Authority liaison: filings, fee strategy, tracking, and structured query responses.
- Pharmacovigilance: local safety workflows, ICSR submissions, and RMP alignment.
Outcomes Assured
- First-time-right submissions that are entirely compliant with country regulations and industry best practices
- Faster approvals enabled by clean administrative packages and timely, well-supported responses to agency questions.
- Sustainable compliance via integrated PV, labeling governance, and disciplined change control across the product lifecycle.