DossierTrans

Colombia 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 Colombia-specific dossiers and technical documents, aligned with the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA).

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 Colombia.

Who We Are

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

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers, ensuring terminology aligns with INVIMA requirements and the local regulatory framework (Decree 677 of 1995, Decree 780 of 2016, among others).

Colombian Regulatory Alignment

Our services are aligned with the requirements of:

• Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) (The principal national regulatory authority)

• Ministerio de Salud y Protección Social (MinSalud)

• Requirements for Registro Sanitario (Sanitary Registration) for medicines, medical devices, foods, and cosmetics.

• Compliance with the Spanish language mandate, particularly Latin American Spanish.

Language Mandate: Spanish

Spanish is the official language of Colombia and is mandated for all consumer-facing materials and critical administrative documentation submitted to INVIMA.

Document TypeLanguage RequirementCompliance NoteDossier (CTD/Local Format)Spanish MandatoryWhile technical documents (Modules 3-5 of CTD) are often accepted in English or Portuguese, INVIMA requires an official translation into Spanish for key administrative, quality (Module 3 Summaries), and clinical summaries.Etiquetado (Labelling) & Prospecto (PIL)Spanish MandatoryThe full patient information leaflet (Prospecto) and all labeling text (Etiquetado) must be translated into clear, regulatory-compliant Spanish. This is non-negotiable for obtaining the Registro Sanitario.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 – Colombia

📘 Dossier & Technical Document Translation

• Translation of dossiers (all modules) into regulatory Spanish (Latin American).

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

• Preparation of documents for official/certified translation (ensuring accuracy before the final certification process).

• Translation of technical documents (SOPs, COAs, Validation reports) from non-Spanish sources into Spanish or English/Portuguese, as acceptable to INVIMA.

🔍 Review of Translated Dossiers

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

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

🛡️ Post-Submission Regulatory Query Handling – Colombia

• Assistance in addressing INVIMA queries (requerimientos), often related to the accuracy or clarity of the Spanish translations, particularly in administrative and quality summaries, and the Prospecto.

• Scientific clarification and regulatory re-wording support.

Why Choose DossierTrans for Colombia?

✅ INVIMA-regulatory-focused translation services.

✅ Expertise in the requirements for Spanish (Latin American) translation and localization.

✅ Specialization in preparing documents for official translation and Apostille/Legalization.

✅ Scientific reviewers ensuring pharmaceutical and technical accuracy in Spanish.

✅ Familiarity with Colombian regulatory decrees for product registration.

Our Commitment

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

DossierTrans – Traduciendo la Ciencia en Aprobación Regulatoria en Colombia.