DossierTrans

Chile 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 Chile-specific dossiers and technical documents, fully aligned with Chilean pharmaceutical and technical regulatory requirements.

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

Who We Are

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

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Institute of Public Health of Chile (ISP) expectations

Chile Regulatory Alignment

Our services are aligned with the requirements of:

• Institute of Public Health (Instituto de Salud Pública – ISP), Chile
• Ministry of Health (Ministerio de Salud – MINSAL), Chile
• National Medicines and Health Products Regulations
• PAHO / WHO-aligned regulatory guidance
• Chilean Customs & Import–Export Authorities

Our Core Services – Chile

📘 Dossier & Technical Document Translation

• Chile-specific national dossier formats
• Administrative, quality, non-clinical & clinical document translations for ISP submissions
• Product information, PILs, labeling & packaging text (Spanish-Chile 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 ISP guidelines, PAHO/WHO, USP / BP / Ph. Eur. references

🛡️ Post-Submission Regulatory Query Handling – Chile

• ISP deficiency letters and regulatory queries related to translated content
• Scientific clarification and Chile-compliant regulatory re-wording
• Revised translations based on technical and expert assessment comments
• Coordination with local representatives, importers, and MA holders

Languages We Support (Chile-Focused)

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

🌍 International Languages

• English
• German
• French
• Italian
• Portuguese

🇨🇱 Chile Regulatory Language

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

English ↔ Spanish (Chile) | EU Language ↔ Spanish

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

Industries We Serve – Chile

• 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 Chile?

✅ Chile-regulatory-focused translation (not generic translation)
✅ Expertise in ISP & Ministry of Health documentation
✅ Native Chilean Spanish scientific reviewers
✅ Terminology consistency across submissions
✅ Authority-ready, inspection-acceptable documentation
✅ Lifecycle support: variations, renewals & post-approval changes
✅ Strict confidentiality & data security

Global & Chile Regulatory Expertise

Our Chile services support:

• National marketing authorization dossiers
• 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 ISP approval in Chile.

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

DossierTrans – Translating Science into Regulatory Approval in Chile

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