DossierTrans – Zambia

Zambia 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 Zambia-specific dossiers and technical documents, aligned with Zambian regulatory authorities and statutory requirements.

We support Zambian 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 Zambia.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Zambian 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 Zambia-specific MoH / ZAMRA expectations

Zambia Regulatory Alignment

Our services are aligned with the requirements of:

• Zambia Medicines Regulatory Authority (ZAMRA)
• Ministry of Health (MoH), Republic of Zambia
• Medicines and Allied Substances Act, Zambia
• ZAMRA Guidelines for Medicines & Medical Devices Registration
• WHO prequalification & reliance pathways (where applicable)
• Zambia Bureau of Standards (ZABS)
• Zambia Revenue Authority (ZRA) – Customs Services
• Other applicable import & export regulatory authorities in Zambia

Our Core Services – Zambia

📘 Dossier & Technical Document Translation

• Zambia-specific CTD / non-CTD dossier formats
• Module 1–5 translations for ZAMRA 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 ZAMRA guidelines, MoH requirements, and accepted pharmacopoeias (USP, BP, EP)

🛡️ Post-Submission Regulatory Query Handling – Zambia

• ZAMRA / 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 (Zambia-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 Zambian languages – where required for public-health or NGO documentation

English ↔ Foreign Language

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

Industries We Serve – Zambia

• 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 Zambia?

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

Global & Zambia Regulatory Expertise

Our Zambia services support:

• ZAMRA 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 a ZAMRA approval in Zambia.

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

DossierTrans – Translating Science into Regulatory Approval in Zambia

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