DossierTrans – Egypt

Egypt 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 Egypt-specific dossiers and technical documents, aligned with Egyptian regulatory authorities and statutory requirements.

We support Egyptian 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 Egypt.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Egyptian 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 Egypt-specific EDA / MoH expectations

Egypt Regulatory Alignment

Our services are aligned with the requirements of:

• Egyptian Drug Authority (EDA)
• Central Administration of Pharmaceutical Affairs (CAPA)
• Central Administration for Pharmaceutical Control (CAPC)
• National Organization for Drug Control and Research (NODCAR)
• Egyptian Pharmacopoeia / EDA-accepted international pharmacopoeias (USP, BP, EP)
• General Organization for Export & Import Control (GOEIC)
• Egyptian Customs Authority

Our Core Services – Egypt

📘 Dossier & Technical Document Translation

• Egypt-specific CTD / eCTD / non-CTD dossier formats
• Module 1–5 translations for EDA submissions
• Prescribing information, SmPC, 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 EDA guidance, Egyptian Pharmacopoeia, and regulatory references

🛡️ Post-Submission Regulatory Query Handling – Egypt

• EDA / CAPA / CAPC queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations as per authority observations
• Coordination with applicants, local agents, distributors, and consultants

Languages We Support (Egypt-Focused)

🌍 International Languages

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

🇪🇬 Local & Regional Language Support

• Arabic
• English (Egypt regulatory format)

English ↔ Arabic | Foreign Language ↔ English / Arabic

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

Industries We Serve – Egypt

• 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 Egypt?

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

Global & Egypt Regulatory Expertise

Our Egypt services support:

• EDA product registration & variation dossiers
• Manufacturing & marketing authorization documentation
• Import/export and customs documentation
• Export-support translations for MENA, 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 EDA approval in Egypt.

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

DossierTrans – Translating Science into Regulatory Approval in Egypt

If you’d like next, I can:
✔ Prepare SEO-optimized Egypt landing page content
✔ Create Arabic–English bilingual brochures
✔ Develop EDA-only pharma / medical device / cosmetics versions
✔ Convert this for Libya, Sudan, GCC, Africa, or LATAM