DossierTrans – Nepal

Nepal 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 Nepal-specific dossiers and technical documents, aligned with Nepalese regulatory authorities and statutory requirements.

We support Nepalese 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 Nepal.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Nepal 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 Nepal-specific DDA / MoHP expectations

Nepal Regulatory Alignment

Our services are aligned with the requirements of:

• Department of Drug Administration (DDA), Nepal
• Ministry of Health and Population (MoHP)
• Drug Act, 1978 & Drug Regulations, Nepal
• Nepal Pharmacopoeia / DDA-accepted international pharmacopoeias (IP, BP, USP, EP)
• Department of Food Technology and Quality Control (DFTQC)
• Nepal Customs Department
• Other applicable import & export regulatory authorities in Nepal

Our Core Services – Nepal

📘 Dossier & Technical Document Translation

• Nepal-specific CTD / non-CTD dossier formats
• Module 1–5 translations for DDA Nepal submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (Nepali-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 DDA Nepal guidelines, Nepal Pharmacopoeia, and MoHP references

🛡️ Post-Submission Regulatory Query Handling – Nepal

• DDA / MoHP / DFTQC queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations based on authority observations
• Coordination with applicants, consultants, local agents, and importers

Languages We Support (Nepal-Focused)

🌍 International Languages

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

🇳🇵 Local & Regional Language Support

• Nepali
• English (Nepal regulatory format)

English ↔ Nepali | Foreign Language ↔ English / Nepali

All translations are reviewed by regulatory experts experienced with DDA Nepal and MoHP requirements.

Industries We Serve – Nepal

• 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 Nepal?

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

Global & Nepal Regulatory Expertise

Our Nepal services support:

• DDA Nepal product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Export-support translations for South Asia & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a DDA Nepal approval.

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

DossierTrans – Translating Science into Regulatory Approval in Nepal

If you’d like next, I can:
✔ Prepare SEO-optimized Nepal landing page content
✔ Create Nepali–English bilingual brochures
✔ Develop DDA-only pharma / food / cosmetics versions
✔ Convert this for Bhutan, Sri Lanka, Bangladesh, GCC, Africa, or LATAM