DossierTrans

Paraguay Dossier & Technical Document Translation Services

Precisión. Cumplimiento Regulatorio. Listo para la Autoridad. (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 Paraguay-specific dossiers and technical documents, aligned with the Dirección Nacional de Vigilancia Sanitaria (DINAVISA) under the Ministry of Public Health and Social Welfare (MSPyBS).

We support manufacturers, exporters, importers, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, registrations, and approvals in the Republic of Paraguay.

Who We Are

DossierTrans es un prestador de servicios de traducción regulatoria especializado para el mercado Paraguayo, enfocado exclusivamente en documentación científica, farmacéutica, dispositivos médicos, y documentación técnica.

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers, ensuring terminology aligns with DINAVISA requirements and local regulations (e.g., Decreto N° 5567/2016 for pharmaceutical registration).

Paraguayan Regulatory Alignment

Our services are aligned with the requirements of:

• Dirección Nacional de Vigilancia Sanitaria (DINAVISA) (The principal national regulatory authority)

• Ministerio de Salud Pública y Bienestar Social (MSPyBS)

• MERCOSUR agreements and guidelines, to which Paraguay is a member state (Harmonization of Pharmaceutical/Technical Requirements).

• Requirements for Registro Sanitario (Sanitary Registration).

Language Mandate: Spanish (and Guarani)

Spanish is the language required for all regulatory submissions and consumer-facing materials. While Guarani is also an official language, Spanish is the dominant language for pharmaceutical and technical dossiers.

Document TypeLanguage RequirementCompliance NoteDossier (CTD/MERCOSUR Format)Spanish MandatoryThe dossier must be submitted in Spanish. DINAVISA typically requires an official translation into Spanish for administrative documents and key summaries, even if the source is English or Portuguese (languages common in MERCOSUR trade).Etiquetado (Labelling) & Prospecto (PIL)Spanish MandatoryThe full patient information leaflet (Prospecto) and all labeling text (Etiquetado) must be translated into clear, regulatory-compliant Spanish. Compliance with DINAVISA's labeling font and format requirements is critical.Administrative DocumentsSpanish (Apostille/Certified Translation)Key administrative documents (FSC, CPP, GMP Certificates) originating from non-Spanish speaking countries must be submitted with an accompanying official/certified translation into Spanish, often requiring legalization via Apostille or local consulate.

Our Core Services – Paraguay

📘 Dossier & Technical Document Translation

• Translation of dossiers (all modules) into regulatory Spanish (Latin American), considering MERCOSUR harmonization.

• Localization and translation of the Prospecto (PIL) and Etiquetado (Labelling) to meet DINAVISA's specific resolution requirements.

• Preparation of documents for official/certified translation required for administrative sections.

• Translation of technical documents (SOPs, COAs, Validation reports) from non-Spanish sources into Spanish.

🔍 Review of Translated Dossiers

• Technical and scientific review of Spanish documentation for accuracy and consistency with DINAVISA standards and regulatory language.

• Review of Prospecto and labeling content against current Paraguayan regulations.

🛡️ Post-Submission Regulatory Query Handling – Paraguay

• Assistance in addressing DINAVISA queries (observaciones), often related to the clarity or completeness of the Spanish translations in the administrative and quality sections, or Prospecto content.

• Scientific clarification and regulatory re-wording support.

Why Choose DossierTrans for Paraguay?

✅ DINAVISA-regulatory-focused translation services.

✅ Expertise in Spanish (Latin American) translation and localization, adapted to Paraguayan context.

✅ Familiarity with MERCOSUR regional harmonization requirements.

✅ Scientific reviewers ensuring pharmaceutical and technical accuracy in Spanish.

✅ Specialization in preparing documents for the required official/certified translation.

Our Commitment

DossierTrans delivers high-precision translations into Spanish, ensuring scientific integrity and full compliance with DINAVISA’s regulatory requirements, facilitating your product registration in Paraguay.

DossierTrans – Traduciendo la Ciencia en Aprobación Regulatoria en Paraguay.