DossierTrans

Fiji Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for Fiji-specific dossiers and technical documents, fully aligned with Fiji national regulatory requirements and Pacific-region guidelines.

We support manufacturers, marketing authorization holders, importers, exporters, and regulatory consultants targeting Fiji with precise, technically accurate, and authority-acceptable translations, ensuring smooth registrations, evaluations, inspections, and approvals in Fiji.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Fiji pharmaceutical and technical market, focused exclusively on scientific, pharmaceutical, medical device, and regulatory documentation.

All translations are performed and reviewed by subject-matter experts and regulatory professionals experienced with Fiji and PIC regulatory systems—not general translators.

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Ministry of Health & Medical Services (MHMS) and Fiji Medicines Authority (FMA) expectations

Fiji Regulatory Alignment

Our services are aligned with the requirements of:

• Fiji Medicines Authority (FMA)
• Ministry of Health & Medical Services (MHMS), Fiji
• Poisons Act & Medicines regulatory framework of Fiji
• WHO-prequalified and PIC/S-aligned regulatory guidance (where applicable)
• Fiji Customs & Import–Export Authorities

Our Core Services – Fiji

📘 Dossier & Technical Document Translation

• Fiji-specific national and WHO-aligned dossier formats
• Administrative, quality, non-clinical & clinical document translations for FMA submissions
• Product information, PILs, labeling & packaging text (English-compliant)
• Stability, validation, bioequivalence & study reports
• SOPs, specifications, COAs, SDS & technical files
• Import registration, marketing authorization, GMP & licensing documentation

🔍 Review of Translated Dossiers

• Scientific and regulatory review of translated documents
• Cross-verification against source (English) dossiers
• Identification of terminology errors, inconsistencies & compliance gaps
• Alignment with WHO Guidelines, BP / USP / Ph. Eur. references accepted by FMA

🛡️ Post-Submission Regulatory Query Handling – Fiji

• FMA deficiency letters and regulatory queries related to translated content
• Scientific clarification and regulator-acceptable re-wording
• Revised translations based on assessment and review comments
• Coordination with local agents, importers, and MA holders

Languages We Support (Fiji-Focused)

We provide professional, native-level regulatory translations relevant to Fiji registrations:

🌍 International Languages

• English (official regulatory language)
• French
• German
• Spanish
• Chinese
• Japanese

English ↔ International Languages

All translations are reviewed by scientific and regulatory experts familiar with Fiji pharmaceutical legislation.

Industries We Serve – Fiji

• Pharmaceuticals & APIs
• Medical Devices & Diagnostics
• Cosmetics & Personal Care Products
• Herbal & Traditional Medicines
• Food Supplements & Nutraceuticals
• Chemicals & Disinfectants
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Fiji?

✅ Fiji-regulatory-focused translation (not generic translation)
✅ Expertise in FMA & MHMS documentation
✅ WHO- and PIC/S-aligned scientific reviewers
✅ Terminology consistency across submissions
✅ Authority-ready, review-acceptable documentation
✅ Post-approval lifecycle support
✅ Strict confidentiality & data security

Global & Fiji Regulatory Expertise

Our Fiji services support:

• National marketing authorization dossiers
• Import & export regulatory documentation
• WHO-supported registration pathways
• Post-approval variations, renewals & compliance updates

Our Commitment

At DossierTrans, we understand that even a single mistranslated statement can delay or block a product approval in Fiji.

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

DossierTrans – Translating Science into Regulatory Approval in Fiji

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