DossierTrans

Brazil Dossier & Technical Document Translation Services

Preciso. Em Conformidade Regulatória. Pronto para a Autoridade. (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 Brazil-specific dossiers and technical documents, aligned with the Agência Nacional de Vigilância Sanitária (ANVISA).

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

Who We Are

DossierTrans é um prestador de serviços de tradução regulatória especializado para o mercado Brasileiro, focado exclusivamente em documentação científica, farmacêutica, dispositivos médicos e documentação técnica.

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers, ensuring terminology aligns with ANVISA requirements and local technical standards.

Brazilian Regulatory Alignment

Our services are aligned with the requirements of:

• Agência Nacional de Vigilância Sanitária (ANVISA) (The principal national regulatory authority)

• Resoluções da Diretoria Colegiada (RDCs) and Instructions Normative (INs) issued by ANVISA.

• Requirements for Registro de Medicamentos, Cadastro de Produtos, and Certificado de Boas Práticas de Fabricação (CBPF).

• Compliance with the Português Brasileiro language mandate.

Language Mandate: Brazilian Portuguese

Brazilian Portuguese is the official language of Brazil and is mandated for all consumer-facing materials and crucial administrative/quality documentation submitted to ANVISA.

Document TypeLanguage RequirementCompliance NoteDossier (CTD/Local Format)Portuguese (Brazilian) MandatoryWhile technical documents (Modules 3-5 of CTD) are often accepted in English or Spanish, ANVISA frequently requires a certified translation (Tradução Juramentada) into Portuguese for key administrative, quality, and clinical summaries.Bula (Package Insert/PIL)Portuguese (Brazilian) MandatoryThe full package insert (Bula) must be translated into clear, regulatory-compliant Portuguese. This is non-negotiable for market authorization.Labelling & ArtworkPortuguese (Brazilian) MandatoryAll labeling and artwork text must be in Portuguese.Administrative DocumentsPortuguese (Tradução Juramentada)Key administrative documents (FSC, CPP, GMP Certificates) must be submitted with an accompanying Tradução Juramentada (Sworn Translation) into Brazilian Portuguese, performed by a certified Brazilian translator.

Our Core Services – Brazil

📘 Dossier & Technical Document Translation

• Translation of dossiers (all modules) into regulatory Portuguese.

• Localization and translation of the Bula (Package Insert) and Rotulagem (Labelling) to meet ANVISA's specific RDCs (e.g., RDC 47/2009 for Bula content).

• Preparation of documents for Tradução Juramentada (identifying which documents require sworn translation and ensuring accuracy beforehand).

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

🔍 Review of Translated Dossiers

• Technical and scientific review of Portuguese documentation for accuracy and consistency with ANVISA standards and regulatory language.

• Review of Bula and labeling content against current RDCs.

🛡️ Post-Submission Regulatory Query Handling – Brazil

• Assistance in addressing ANVISA queries (Exigências), often related to the accuracy or clarity of the Portuguese translations, particularly in Modules 1 and 3, and the Bula.

• Scientific clarification and regulatory re-wording support.

Why Choose DossierTrans for Brazil?

✅ ANVISA-regulatory-focused translation services.

✅ Expertise in the requirements for Brazilian Portuguese translation and localization.

✅ Specialization in preparing documents for Tradução Juramentada.

✅ Scientific reviewers ensuring pharmaceutical and technical accuracy in Portuguese.

✅ Familiarity with RDC guidelines for Bula and labeling.

Our Commitment

DossierTrans delivers high-precision translations into Brazilian Portuguese, ensuring scientific integrity and full compliance with ANVISA’s complex regulatory requirements, facilitating your product registration in the largest market in Latin America.

DossierTrans – Traduzindo a Ciência em Aprovação Regulatória no Brasil.