DossierTrans

South Africa Dossier & Technical Document Translation Services

Accurate. SAHPRA-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, fully aligned with South African regulatory authorities, statutory requirements, and submission practices.

We support South African manufacturers, importers, distributors, MAHs, regulatory consultants, CROs, and global companies targeting the South African market with precise, technically accurate, and SAHPRA-acceptable translations, ensuring smooth submissions, reviews, approvals, inspections, and lifecycle compliance in South Africa.

Who We Are

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

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers—not general translators.

We ensure that translated dossiers consistently maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with SAHPRA / MCC-legacy / national guideline expectations

South Africa Regulatory Alignment

Our services are fully aligned with the requirements of:

• South African Health Products Regulatory Authority (SAHPRA)
• Department of Health – South Africa
• Medicines Control Council (MCC) legacy dossiers
• South African Bureau of Standards (SABS) – where applicable
• National Regulator for Compulsory Specifications (NRCS)
• South African Revenue Service (SARS) – Customs & Excise

Our Core Services – South Africa

📘 Dossier & Technical Document Translation

• South Africa–specific CTD / eCTD / non-CTD dossier formats
• Module 1–5 translations for SAHPRA submissions
• Package inserts, patient information leaflets (PILs) & labeling
• SmPC-equivalent professional information documents
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS, MSDS & technical files
• Import, distribution & registration documentation

🔍 Review of Translated Dossiers

• Technical and scientific review of translated documents
• Cross-verification with source (English or original language) dossiers
• Identification of terminology errors, inconsistencies & compliance gaps
• Alignment with SAHPRA guidelines, South African Pharmacopoeia references, ICH & WHO standards

🛡️ Post-Submission Regulatory Query Handling – South Africa

• SAHPRA deficiency letters & clarification requests related to translated content
• Scientific clarification and SAHPRA-style regulatory re-wording support
• Revised translations addressing authority observations
• Coordination with local agents, applicants, MAHs & regulatory consultants

Languages We Support (South Africa-Focused)

We provide professional, native-level regulatory translations relevant to South African submissions:

🌍 International Languages

• English (primary regulatory language)
• French
• German
• Spanish
• Portuguese
• Russian
• Arabic
• Chinese (Simplified & Traditional)

🇿🇦 Regional & Local Language Support (as required)

• Afrikaans
• Other local languages – on request (for patient-facing or public-health documentation)

Foreign Language ↔ English

All translations are reviewed by scientific and regulatory experts familiar with SAHPRA expectations.

Industries We Serve – South Africa

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Biologics & Biosimilars
• Medical Devices & IVDs
• Vaccines & Public Health Products
• Cosmetics & OTC Products
• Food, Nutraceuticals & Supplements
• Chemicals & Specialty Materials

Why Choose DossierTrans for South Africa?

✅ SAHPRA-focused regulatory translation (not generic translation)
✅ Expertise in CTD, eCTD & legacy MCC dossiers
✅ Native-language scientific & regulatory reviewers
✅ Consistent terminology aligned with SAHPRA guidance
✅ Authority-ready documentation
✅ End-to-end support including post-submission queries
✅ Strict confidentiality & data security

Global & South Africa Regulatory Expertise

Our South Africa services support:

• SAHPRA registrations & variations
• Import & distribution authorization dossiers
• Export-support translations for ROW markets
• Post-approval changes, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay a SAHPRA approval or trigger extended review cycles.

That’s why we deliver precision-driven, regulator-acceptable translations, aligned with South Africa’s regulatory and compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in South Africa