DossierTrans – Ghana

Ghana 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 Ghana-specific dossiers and technical documents, aligned with Ghanaian regulatory authorities and statutory requirements.

We support Ghanaian 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 Ghana.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Ghana 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 Ghana-specific FDA / MoH expectations

Ghana Regulatory Alignment

Our services are aligned with the requirements of:

• Food and Drugs Authority (FDA), Ghana
• Ministry of Health (MoH), Republic of Ghana
• Public Health Act, 2012 (Act 851)
• FDA Ghana Guidelines for Medicines, Medical Devices & Cosmetics
• Traditional Medicines Practice Council (TMPC) – where applicable
• Ghana Standards Authority (GSA)
• Ghana Revenue Authority (Customs Division)
• Other applicable import & export regulatory authorities in Ghana

Our Core Services – Ghana

📘 Dossier & Technical Document Translation

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

🛡️ Post-Submission Regulatory Query Handling – Ghana

• FDA Ghana / 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 (Ghana-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 Ghanaian languages – where required for public-health or NGO documentation

English ↔ Foreign Language

All translations are reviewed by regulatory experts experienced with FDA Ghana requirements.

Industries We Serve – Ghana

• 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 Ghana?

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

Global & Ghana Regulatory Expertise

Our Ghana services support:

• FDA Ghana 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 FDA Ghana approval.

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

DossierTrans – Translating Science into Regulatory Approval in Ghana

If you want next, I can:
✔ Prepare SEO-optimized Ghana landing page content
✔ Create English-focused NGO / donor documentation versions
✔ Develop FDA-only pharma, medical device, food, or herbal versions
✔ Convert this for Nigeria, Sierra Leone, Liberia, ECOWAS, or Africa