DossierTrans – Saudi Arabia

Saudi Arabia 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 Saudi Arabia–specific dossiers and technical documents, aligned with Saudi regulatory authorities and statutory requirements.

We support Saudi 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 the Kingdom of Saudi Arabia (KSA).

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Saudi 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 Saudi-specific SFDA / MoH expectations

Saudi Arabia Regulatory Alignment

Our services are aligned with the requirements of:

• Saudi Food and Drug Authority (SFDA)
• Ministry of Health (MoH), Kingdom of Saudi Arabia
• Saudi Pharmaceutical Registration Regulations
• GCC Harmonized Technical Requirements (GCC-CTD / eCTD)
• Saudi Standards, Metrology and Quality Organization (SASO)
• Zakat, Tax and Customs Authority (ZATCA)
• Saudi Customs & Import–Export Authorities

Our Core Services – Saudi Arabia

📘 Dossier & Technical Document Translation

• Saudi Arabia–specific GCC-CTD / eCTD dossier formats
• Module 1–5 translations for SFDA submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (Arabic-compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, import license & 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 SFDA guidelines, GCC requirements, and accepted pharmacopoeias (USP, BP, EP)

🛡️ Post-Submission Regulatory Query Handling – Saudi Arabia

• SFDA / MoH queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations based on authority observations
• Coordination with applicants, local agents, and Saudi representatives

Languages We Support (Saudi Arabia-Focused)

🌍 International Languages

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

🇸🇦 Local & Regional Language Support

• Arabic
• English (Saudi regulatory format)

English ↔ Arabic | Foreign Language ↔ English / Arabic

All translations are reviewed by regulatory experts experienced with SFDA and GCC submission requirements.

Industries We Serve – Saudi Arabia

• Pharmaceuticals & APIs
• Medical Devices
• Vaccines & Biologicals
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Herbal & Traditional Medicines
• Essential Oils & Fragrances
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Saudi Arabia?

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

Global & Saudi Regulatory Expertise

Our Saudi Arabia services support:

• SFDA product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Export-support translations for GCC, Middle East & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject an SFDA approval in Saudi Arabia.

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

DossierTrans – Translating Science into Regulatory Approval in Saudi Arabia

If you want next, I can:
✔ Prepare SEO-optimized Saudi Arabia landing page content
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