DossierTrans – Namibia

Namibia 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 Namibia-specific dossiers and technical documents, aligned with Namibian regulatory authorities and statutory requirements.

We support Namibian 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 Namibia.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Namibian 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 Namibia-specific MoHSS / NMRC expectations

Namibia Regulatory Alignment

Our services are aligned with the requirements of:

• Ministry of Health and Social Services (MoHSS), Republic of Namibia
• Namibia Medicines Regulatory Council (NMRC)
• Medicines and Related Substances Control Act, Namibia
• NMRC Guidelines for Medicines Registration
• WHO prequalification & reliance pathways (where applicable)
• Namibia Standards Institution (NSI)
• Namibia Revenue Agency (NamRA) – Customs & Excise
• Other applicable import & export regulatory authorities in Namibia

Our Core Services – Namibia

📘 Dossier & Technical Document Translation

• Namibia-specific CTD / non-CTD dossier formats
• Module 1–5 translations for NMRC submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (English-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 NMRC guidelines, MoHSS requirements, and accepted pharmacopoeias (USP, BP, EP)

🛡️ Post-Submission Regulatory Query Handling – Namibia

• NMRC / MoHSS 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 (Namibia-Focused)

🌍 International Languages

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

🇳🇦 Local & Regional Language Support

• English (official regulatory language)
• Local languages – where required for public-health or NGO documentation

English ↔ Foreign Language

All translations are reviewed by regulatory experts experienced with NMRC Namibia requirements.

Industries We Serve – Namibia

• 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 Namibia?

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

Global & Namibia Regulatory Expertise

Our Namibia services support:

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

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject an NMRC approval in Namibia.

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

DossierTrans – Translating Science into Regulatory Approval in Namibia

If you’d like next, I can:
✔ Prepare SEO-optimized Namibia landing page content
✔ Create English-focused NGO / donor documentation versions
✔ Develop NMRC-only pharma / medical device / food versions
✔ Convert this for Botswana, Zambia, South Africa, SADC, Africa, or LATAM