DossierTrans

Guatemala 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 Guatemala-specific dossiers and technical documents, fully aligned with Guatemalan regulatory requirements and Central American harmonized guidelines.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Guatemalan 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 Guatemala and Central American regulations—not general translators.

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Ministry of Public Health and Social Assistance (MSPAS) expectations

Guatemala Regulatory Alignment

Our services are aligned with the requirements of:

• Ministry of Public Health and Social Assistance (MSPAS), Guatemala
• Department of Regulation and Control of Pharmaceutical Products
• Central American Technical Regulations (RTCA)
• Pan American Health Organization (PAHO) / WHO guidelines
• Guatemala Customs & Import–Export Authorities

Our Core Services – Guatemala

📘 Dossier & Technical Document Translation

• Guatemala-specific national and RTCA-harmonized dossier formats
• Administrative, quality, non-clinical & clinical document translations for MSPAS 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 – Guatemala

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

Languages We Support (Guatemala-Focused)

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

🌍 International Languages

• English
• German
• French
• Italian
• Portuguese

🇬🇹 Guatemala 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 Guatemalan legislation.

Industries We Serve – Guatemala

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

Why Choose DossierTrans for Guatemala?

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

Global & Guatemala Regulatory Expertise

Our Guatemala 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 Guatemala.

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

DossierTrans – Translating Science into Regulatory Approval in Guatemala

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