DossierTrans
Argentina 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 Argentina-specific dossiers and technical documents, fully aligned with Argentine pharmaceutical and technical regulatory requirements and MERCOSUR guidelines.
We support manufacturers, marketing authorization holders, importers, exporters, distributors, and regulatory consultants targeting Argentina with precise, technically accurate, and authority-acceptable translations, ensuring smooth registrations, evaluations, inspections, and approvals in Argentina.
Who We Are
DossierTrans is a specialized regulatory translation service provider for the Argentine 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 Argentina and MERCOSUR regulations—not general translators.
We ensure that translated dossiers maintain:
• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with National Administration of Drugs, Food and Medical Technology (ANMAT) expectations
Argentina Regulatory Alignment
Our services are aligned with the requirements of:
• National Administration of Drugs, Food and Medical Technology (ANMAT)
• Ministry of Health, Argentine Republic
• MERCOSUR pharmaceutical regulatory framework
• Argentine Pharmacopoeia & recognized international references
• Argentina Customs & Import–Export Authorities
Our Core Services – Argentina
📘 Dossier & Technical Document Translation
• Argentina-specific national and MERCOSUR-aligned dossier formats
• Administrative, quality, non-clinical & clinical document translations for ANMAT submissions
• Product information, PILs, labeling & packaging text (Spanish-compliant – Argentina)
• 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 ANMAT guidelines, MERCOSUR standards, USP / BP / Ph. Eur. references
🛡️ Post-Submission Regulatory Query Handling – Argentina
• ANMAT deficiency letters and regulatory queries related to translated content
• Scientific clarification and Argentina-compliant regulatory re-wording
• Revised translations based on technical assessment reports
• Coordination with local MA holders, importers, and regulatory agents
Languages We Support (Argentina-Focused)
We provide professional, native-level regulatory translations relevant to Argentina registrations:
🌍 International Languages
• English
• German
• French
• Italian
• Portuguese
🇦🇷 Argentina Regulatory Language
• Spanish (Argentina) – mandatory for all national submissions, labeling & PILs
English ↔ Spanish (Argentina) | EU Language ↔ Spanish
All translations are reviewed by scientific and regulatory experts familiar with Argentine pharmaceutical legislation.
Industries We Serve – Argentina
• Pharmaceuticals & APIs
• Medical Devices & Diagnostics
• Cosmetics & Personal Care Products
• Herbal & Traditional Medicinal Products
• Food Supplements & Nutraceuticals
• Chemicals & Biocides
• Industrial & Specialty Chemicals
Why Choose DossierTrans for Argentina?
✅ Argentina-regulatory-focused translation (not generic translation)
✅ Expertise in ANMAT & MERCOSUR documentation
✅ Native Argentine Spanish scientific reviewers
✅ Terminology consistency across submissions
✅ Authority-ready, inspection-acceptable documentation
✅ Lifecycle support: variations, renewals & post-approval changes
✅ Strict confidentiality & data security
Global & Argentina Regulatory Expertise
Our Argentina services support:
• National marketing authorization dossiers
• MERCOSUR-aligned 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 jeopardize an ANMAT approval.
That’s why we deliver precision-driven, regulator-acceptable translations, fully aligned with Argentina compliance expectations—every time.
DossierTrans – Translating Science into Regulatory Approval in Argentina
If you want next, I can:
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