DossierTrans – Tanzania

Tanzania Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, technical review, and regulatory query support for Tanzania-specific dossiers and technical documents, aligned with Tanzanian regulatory authorities and statutory requirements.

We support Tanzanian manufacturers, importers, exporters, marketing authorization holders, NGOs, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and regulatory approvals in Tanzania.

Who We Are

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

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

We ensure every translated dossier preserves:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Tanzania-specific TMDA / MoH expectations

Tanzania Regulatory Alignment

Our services are aligned with the requirements of:

• Tanzania Medicines and Medical Devices Authority (TMDA)
• Ministry of Health (MoH), United Republic of Tanzania
• Medicines and Medical Devices Act, Tanzania
• TMDA Guidelines for Medicines & Medical Devices Registration
• WHO prequalification & reliance pathways (where applicable)
• Tanzania Bureau of Standards (TBS)
• Tanzania Revenue Authority (TRA) – Customs & Excise
• Other applicable import & export regulatory authorities in Tanzania

Our Core Services – Tanzania

📘 Dossier & Technical Document Translation

• Tanzania-specific CTD / non-CTD dossier formats
• Module 1–5 translations for TMDA submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (English / Swahili compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, import permit & export documentation

🔍 Review of Translated Dossiers

• Scientific and technical review of translated documents
• Cross-verification with source-language dossiers
• Identification of terminology errors, inconsistencies & regulatory gaps
• Alignment with TMDA guidelines, MoH requirements, and accepted pharmacopoeias (USP, BP, EP)

🛡️ Post-Submission Regulatory Query Handling – Tanzania

• TMDA / MoH queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations based on authority observations
• Coordination with applicants, local agents, NGOs, and distributors

Languages We Support (Tanzania-Focused)

🌍 International Languages

• English
• French
• German
• Spanish
• Italian
• Portuguese
• Russian
• Arabic
• Chinese (Simplified & Traditional)
• Japanese
• Korean

🇹🇿 Local & Regional Language Support

• English (primary regulatory language)
• Swahili (Kiswahili) – where required for public-facing labels, leaflets, or NGO documentation

English ↔ Swahili | Foreign Language ↔ English / Swahili

All translations are reviewed by regulatory experts experienced with TMDA requirements.

Industries We Serve – Tanzania

• Pharmaceuticals & APIs
• Medical Devices
• Vaccines & Biologicals
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Herbal & Traditional Medicines
• Essential Oils & Fragrances
• Agrochemicals
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Tanzania?

✅ Tanzania-regulatory-focused translation (not generic translation)
✅ Proven expertise in TMDA documentation
✅ Native-language scientific & regulatory reviewers
✅ Terminology consistency across Tanzania submissions
✅ Authority-ready, inspection-friendly documentation
✅ End-to-end support including post-submission regulatory queries
✅ Strict confidentiality & data security

Global & Tanzania Regulatory Expertise

Our Tanzania services support:

• TMDA product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Import permit & customs documentation
• Export-support translations for EAC, East Africa & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a TMDA approval in Tanzania.

That’s why we deliver precision-driven, regulator-acceptable translations, fully aligned with Tanzanian compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Tanzania

If you’d like next, I can:
✔ Prepare SEO-optimized Tanzania landing page content
✔ Create English–Swahili bilingual brochures
✔ Develop TMDA-only pharma / medical device / food versions
✔ Convert this for Kenya, Uganda, Rwanda, EAC, Africa, or LATAM