DossierTrans

Costa Rica Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for Costa Rica–specific dossiers and technical documents, fully aligned with Costa Rican regulatory requirements and Central American harmonized guidelines.

We support manufacturers, marketing authorization holders, importers, exporters, and regulatory consultants targeting Costa Rica with precise, technically accurate, and authority-acceptable translations, ensuring smooth registrations, evaluations, inspections, and approvals in Costa Rica.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Costa Rican pharmaceutical and technical market, focused exclusively on scientific, pharmaceutical, medical device, and regulatory documentation.

All translations are performed and reviewed by subject-matter experts and regulatory professionals experienced with Costa Rica and Central American regulations—not general translators.

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Ministry of Health (Ministerio de Salud) and national regulatory expectations

Costa Rica Regulatory Alignment

Our services are aligned with the requirements of:

• Ministry of Health (Ministerio de Salud), Costa Rica
• Drug Registration Directorate (Dirección de Regulación de Productos de Interés Sanitario)
• Central American Technical Regulations (RTCA)
• Pan American Health Organization (PAHO) / WHO guidelines
• Costa Rica Customs & Import–Export Authorities

Our Core Services – Costa Rica

📘 Dossier & Technical Document Translation

• Costa Rica–specific national and RTCA-harmonized dossier formats
• Administrative, quality, non-clinical & clinical document translations for Ministry of Health submissions
• Product information, PILs, labeling & packaging text (Spanish-compliant)
• Stability, validation, bioequivalence & study reports
• SOPs, specifications, COAs, SDS & technical files
• Import registration, marketing authorization, GMP & licensing documentation

🔍 Review of Translated Dossiers

• Scientific and regulatory review of translated documents
• Cross-verification against source (English) dossiers
• Identification of terminology errors, inconsistencies & compliance gaps
• Alignment with RTCA, PAHO/WHO, USP / BP / Ph. Eur. references accepted by authorities

🛡️ Post-Submission Regulatory Query Handling – Costa Rica

• Ministry of Health deficiency letters and regulatory queries related to translated content
• Scientific clarification and Costa Rica–compliant regulatory re-wording
• Revised translations based on technical assessment comments
• Coordination with local representatives, importers, and MA holders

Languages We Support (Costa Rica–Focused)

We provide professional, native-level regulatory translations relevant to Costa Rica registrations:

🌍 International Languages

• English
• German
• French
• Italian
• Portuguese

🇨🇷 Costa Rica Regulatory Language

• Spanish – mandatory for national submissions, labeling & PILs

English ↔ Spanish | EU Language ↔ Spanish

All translations are reviewed by scientific and regulatory experts familiar with Costa Rican legislation.

Industries We Serve – Costa Rica

• Pharmaceuticals & APIs
• Medical Devices & Diagnostics
• Cosmetics & Personal Care Products
• Herbal & Natural Products
• Food Supplements & Nutraceuticals
• Chemicals & Disinfectants
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Costa Rica?

✅ Costa Rica-regulatory-focused translation (not generic translation)
✅ Expertise in Ministerio de Salud & RTCA documentation
✅ Native Spanish scientific reviewers
✅ Terminology consistency across submissions
✅ Authority-ready, review-acceptable documentation
✅ Post-approval lifecycle support
✅ Strict confidentiality & data security

Global & Costa Rica Regulatory Expertise

Our Costa Rica services support:

• National marketing authorization dossiers
• Central American harmonized registration pathways
• Import & export regulatory documentation
• Post-approval variations, renewals & compliance updates

Our Commitment

At DossierTrans, we understand that even a single mistranslated statement can delay or block an approval in Costa Rica.

That’s why we deliver precision-driven, regulator-acceptable translations, fully aligned with Costa Rica compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Costa Rica

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