DossierTrans

Cuba 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 Cuba-specific dossiers and technical documents, fully aligned with Cuban pharmaceutical and technical regulatory requirements.

We support manufacturers, state enterprises, importers, exporters, and regulatory consultants targeting Cuba with precise, technically accurate, and authority-acceptable translations, ensuring smooth registrations, evaluations, inspections, and approvals in Cuba.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Cuban 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 Cuban regulations—not general translators.

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Cuban Ministry of Public Health (MINSAP) and CECMED expectations

Cuba Regulatory Alignment

Our services are aligned with the requirements of:

• Ministry of Public Health (MINSAP), Republic of Cuba
• Center for State Control of Medicines, Equipment and Medical Devices (CECMED)
• National Public Health and State pharmaceutical regulations
• WHO / PAHO-aligned regulatory guidance (as adopted by Cuba)
• Cuban Customs & Import–Export Authorities

Our Core Services – Cuba

📘 Dossier & Technical Document Translation

• Cuba-specific national dossier formats
• Administrative, quality, non-clinical & clinical document translations for CECMED submissions
• Product information, PILs, labeling & packaging text (Spanish-compliant)
• Stability, validation, bioequivalence & study reports
• SOPs, specifications, COAs, SDS & technical files
• Import authorization, marketing authorization & GMP 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 CECMED guidelines, WHO / PAHO, USP / BP / Ph. Eur. references

🛡️ Post-Submission Regulatory Query Handling – Cuba

• CECMED deficiency letters and expert queries related to translated content
• Scientific clarification and Cuba-compliant regulatory re-wording
• Revised translations based on technical and expert assessment reports
• Coordination with state importers, local agents, and regulatory representatives

Languages We Support (Cuba-Focused)

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

🌍 International Languages

• English
• French
• German
• Italian
• Portuguese

🇨🇺 Cuba Regulatory Language

• Spanish – mandatory for all national submissions, labeling & PILs

English ↔ Spanish | EU Language ↔ Spanish

All translations are reviewed by scientific and regulatory experts familiar with Cuban pharmaceutical legislation.

Industries We Serve – Cuba

• Pharmaceuticals & APIs
• Medical Devices & Diagnostics
• Vaccines & Biologics
• Cosmetics & Personal Care Products
• Herbal & Natural Medicinal Products
• Food Supplements & Nutraceuticals
• Chemicals & Disinfectants

Why Choose DossierTrans for Cuba?

✅ Cuba-regulatory-focused translation (not generic translation)
✅ Expertise in MINSAP & CECMED documentation
✅ Native Spanish scientific reviewers
✅ Terminology consistency across submissions
✅ Authority-ready, expert-review-acceptable documentation
✅ Support for public-sector and state procurement dossiers
✅ Strict confidentiality & data security

Global & Cuba Regulatory Expertise

Our Cuba services support:

• National marketing authorization dossiers
• State import and procurement documentation
• Export-support translations for public health programs
• Post-approval variations, renewals & compliance updates

Our Commitment

At DossierTrans, we understand that even a single mistranslated statement can delay or block a product approval in Cuba.

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

DossierTrans – Translating Science into Regulatory Approval in Cuba

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