DossierTrans – The Gambia

The Gambia 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 Gambia-specific dossiers and technical documents, aligned with Gambian regulatory authorities and statutory requirements.

We support Gambian 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 The Gambia.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Gambian 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 Gambia-specific MoH / Medicines Control Agency expectations

The Gambia Regulatory Alignment

Our services are aligned with the requirements of:

• Medicines Control Agency (MCA), The Gambia
• Ministry of Health (MoH), Republic of The Gambia
• Medicines and Related Products Act, The Gambia
• MCA Guidelines for Medicines Registration
• WHO prequalification & reliance pathways (as applicable)
• Gambia Revenue Authority (Customs & Excise)
• Other applicable import & export regulatory authorities in The Gambia

Our Core Services – The Gambia

📘 Dossier & Technical Document Translation

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

🛡️ Post-Submission Regulatory Query Handling – The Gambia

• MCA / 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 (Gambia-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 MCA Gambia requirements.

Industries We Serve – The Gambia

• 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 The Gambia?

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

Global & Gambia Regulatory Expertise

Our Gambia services support:

• MCA 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 an MCA approval in The Gambia.

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

DossierTrans – Translating Science into Regulatory Approval in The Gambia

If you want next, I can:
✔ Prepare SEO-optimized Gambia landing page content
✔ Create English-focused NGO / donor documentation versions
✔ Develop MCA-only pharma or WHO-reliance submission versions
✔ Convert this for Ghana, Nigeria, Sierra Leone, ECOWAS, or Africa