DossierTrans – Nigeria

Nigeria 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 Nigeria-specific dossiers and technical documents, aligned with Nigerian regulatory authorities and statutory requirements.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Nigerian 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 Nigeria-specific NAFDAC / MoH expectations

Nigeria Regulatory Alignment

Our services are aligned with the requirements of:

• National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria
• Federal Ministry of Health (FMoH), Nigeria
• NAFDAC Registration Regulations & Guidelines
• Food, Drugs and Related Products Act, Nigeria
• WHO prequalification & reliance pathways (where applicable)
• Standards Organisation of Nigeria (SON)
• Nigeria Customs Service (NCS)
• Other applicable import & export regulatory authorities in Nigeria

Our Core Services – Nigeria

📘 Dossier & Technical Document Translation

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

🛡️ Post-Submission Regulatory Query Handling – Nigeria

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

Languages We Support (Nigeria-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 Nigerian languages – where required for public-health, NGO, or awareness documentation

English ↔ Foreign Language

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

Industries We Serve – Nigeria

• 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 Nigeria?

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

Global & Nigeria Regulatory Expertise

Our Nigeria services support:

• NAFDAC product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Import permit & customs documentation
• Export-support translations for ECOWAS, West 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 NAFDAC approval in Nigeria.

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

DossierTrans – Translating Science into Regulatory Approval in Nigeria

If you’d like next, I can:
✔ Prepare SEO-optimized Nigeria landing page content
✔ Create English-focused regulatory brochures
✔ Develop NAFDAC-only pharma / food / cosmetic versions
✔ Convert this for Ghana, Sierra Leone, Liberia, ECOWAS, Africa, or LATAM