DossierTrans

Venezuela 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 Venezuela-specific dossiers and technical documents, fully aligned with Venezuelan pharmaceutical and technical regulatory requirements.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Venezuelan 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 Venezuela and Latin American regulations—not general translators.

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Ministry of Popular Power for Health (MPPS) and INHRR expectations

Venezuela Regulatory Alignment

Our services are aligned with the requirements of:

• Ministry of Popular Power for Health (MPPS), Venezuela
• National Institute of Hygiene “Rafael Rangel” (INHRR)
• National medicines, biologicals, and medical device regulations
• PAHO / WHO-aligned regulatory guidance (as adopted in Venezuela)
• Venezuela Customs & Import–Export Authorities

Our Core Services – Venezuela

📘 Dossier & Technical Document Translation

• Venezuela-specific national dossier formats
• Administrative, quality, non-clinical & clinical document translations for MPPS / INHRR submissions
• Product information, PILs, labeling & packaging text (Spanish-Venezuela compliant)
• Stability, validation, bioequivalence & clinical 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 INHRR guidelines, PAHO/WHO, USP / BP / Ph. Eur. references

🛡️ Post-Submission Regulatory Query Handling – Venezuela

• MPPS / INHRR deficiency letters and regulatory queries related to translated content
• Scientific clarification and Venezuela-compliant regulatory re-wording
• Revised translations based on technical and expert assessment reports
• Coordination with local MA holders, importers, distributors, and regulatory agents

Languages We Support (Venezuela-Focused)

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

🌍 International Languages

• English
• German
• French
• Italian
• Portuguese

🇻🇪 Venezuela Regulatory Language

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

English ↔ Spanish (Venezuela) | EU Language ↔ Spanish

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

Industries We Serve – Venezuela

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

Why Choose DossierTrans for Venezuela?

✅ Venezuela-regulatory-focused translation (not generic translation)
✅ Expertise in MPPS & INHRR documentation
✅ Native Venezuelan Spanish scientific reviewers
✅ Terminology consistency across submissions
✅ Authority-ready, expert-review-acceptable documentation
✅ Support for public-sector & institutional dossiers
✅ Strict confidentiality & data security

Global & Venezuela Regulatory Expertise

Our Venezuela services support:

• National marketing authorization dossiers
• Import authorization & institutional procurement documentation
• Export-support translations for LATAM & ROW markets
• 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 Venezuela.

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

DossierTrans – Translating Science into Regulatory Approval in Venezuela

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