DossierTrans

South Africa 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 South Africa-specific dossiers and technical documents, aligned with the South African Health Products Regulatory Authority (SAHPRA).

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 South Africa (RSA).

Who We Are

DossierTrans is a specialized regulatory translation service provider for the South African market, focused exclusively on scientific, pharmaceutical, medical device, and technical documentation.

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers, ensuring terminology aligns with SAHPRA requirements and the Common Technical Document (CTD) format used in the RSA.

South African Regulatory Alignment

Our services are aligned with the requirements of:

• South African Health Products Regulatory Authority (SAHPRA) (The principal national regulatory authority)

• Medicines and Related Substances Act, 101 of 1965 (as amended)

• CTD/eCTD format guidelines as mandated by SAHPRA for medicines and IVDs.

• Requirements for product registration (New Chemical Entity, Generics, Medical Devices).

Language Mandate: English

English is the primary language for regulatory documentation in South Africa. While South Africa has 11 official languages, English is the required language for all official submissions to SAHPRA and is the language used for primary labeling and patient information.

Document TypeLanguage RequirementCompliance NoteDossier (eCTD/CTD Format)English MandatoryThe full dossier (Modules 1-5) must be submitted in English. Non-English source documents must be translated into English, with verification/certification often required.Professional Information (PI)/Package Insert (PI)English MandatoryThe prescribing information (PI) and the Patient Information Leaflet (PIL) must be provided in clear, regulatory-compliant English.Labelling & ArtworkEnglish MandatoryAll essential labeling text must be in English. SAHPRA reviews labeling meticulously for compliance with local advertising codes and safety standards.

Our Core Services – South Africa

📘 Dossier & Technical Document Translation

• Translation of dossiers (all modules) from non-English sources into clear, regulatory-compliant English.

• Translation and localization of Patient Information Leaflets (PIL) and Professional Information (PI) to meet SAHPRA’s structure and content requirements.

• Translation of technical reports (validation, stability, clinical) into regulatory English.

• Preparation of certified English translations for administrative documents (FSC, CPP, GMP Certificates) originating from non-English speaking countries.

🔍 Review of Translated Dossiers

• Technical and scientific review of English dossier content for accuracy and consistency with the CTD format.

• Checking PI/PIL content against local advertising/safety regulations.

🛡️ Post-Submission Regulatory Query Handling – South Africa

• Assistance in addressing SAHPRA queries, often focused on clarity, completeness, or discrepancies in the English technical documentation (e.g., Module 3 quality data).

• Support for re-wording and revision based on authority feedback.

Why Choose DossierTrans for South Africa?

✅ SAHPRA-regulatory-focused translation services.

✅ Expertise in managing documentation under the CTD/eCTD structure.

✅ Scientific reviewers ensuring pharmaceutical and technical accuracy in English.

✅ Familiarity with SAHPRA's specific requirements for PI/PIL and labeling content.

✅ Strict confidentiality and data security.

Our Commitment

DossierTrans delivers high-precision English translations that meet the rigorous scientific and regulatory standards of the South African Health Products Regulatory Authority, facilitating the timely registration and launch of your health products.

DossierTrans – Translating Science into Regulatory Approval in South Africa.