DossierTrans – Tunisia

Tunisia 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 Tunisia-specific dossiers and technical documents, aligned with Tunisian regulatory authorities and statutory requirements.

We support Tunisian manufacturers, importers, exporters, marketing authorization holders, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and regulatory approvals in Tunisia.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Tunisian 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 Tunisia-specific MoH / DPM expectations

Tunisia Regulatory Alignment

Our services are aligned with the requirements of:

• Ministry of Health (Ministère de la Santé), Tunisia
• Directorate of Pharmacy and Medicines (Direction de la Pharmacie et du Médicament – DPM)
• National Agency for Medicines and Health Products (ANMPS)
• Tunisian Medicines Registration Regulations
• Tunisian Pharmacopoeia / MoH-accepted international pharmacopoeias (USP, BP, EP)
• Tunisian Customs Administration
• Other applicable import & export regulatory authorities in Tunisia

Our Core Services – Tunisia

📘 Dossier & Technical Document Translation

• Tunisia-specific CTD / non-CTD dossier formats
• Module 1–5 translations for DPM / ANMPS submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (French / Arabic compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, import authorization & 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 DPM / ANMPS requirements and accepted pharmacopoeial references

🛡️ Post-Submission Regulatory Query Handling – Tunisia

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

Languages We Support (Tunisia-Focused)

🌍 International Languages

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

🇹🇳 Local & Regional Language Support

• French
• Arabic
• English (for import/export dossiers)

English ↔ French | English ↔ Arabic | Foreign Language ↔ English / French / Arabic

All translations are reviewed by regulatory experts experienced with Tunisian MoH, DPM, and ANMPS requirements.

Industries We Serve – Tunisia

• 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 Tunisia?

✅ Tunisia-regulatory-focused translation (not generic translation)
✅ Proven expertise in DPM & ANMPS documentation
✅ Native French & Arabic scientific and regulatory reviewers
✅ Terminology consistency across Tunisian submissions
✅ Authority-ready, inspection-friendly documentation
✅ End-to-end support including post-submission regulatory queries
✅ Strict confidentiality & data security

Global & Tunisia Regulatory Expertise

Our Tunisia services support:

• DPM / ANMPS product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Import license & customs documentation
• Export-support translations for North Africa, MENA & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a regulatory approval in Tunisia.

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

DossierTrans – Translating Science into Regulatory Approval in Tunisia

If you’d like next, I can:
✔ Prepare SEO-optimized Tunisia landing page content
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✔ Develop ANMPS-only pharma / medical device / food versions
✔ Convert this for Algeria, Morocco, Libya, GCC, Africa, or LATAM