DossierTrans

New Zealand Dossier & Technical Document Translation Services

Accurate. Medsafe-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for New Zealand–specific dossiers and technical documents, fully aligned with New Zealand Medicines and Medical Devices Safety Authority (Medsafe) requirements and national regulatory frameworks.

We support New Zealand pharmaceutical manufacturers, sponsors, importers, distributors, CROs, regulatory consultants, and global companies targeting the New Zealand market with precise, technically accurate, and Medsafe-acceptable translations, ensuring smooth submissions, approvals, inspections, and lifecycle compliance in New Zealand.

Who We Are

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

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers—not general translators.

We ensure that translated dossiers consistently maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Medsafe / Ministry of Health guidance expectations

New Zealand Regulatory Alignment

Our services are fully aligned with the requirements of:

• New Zealand Medicines and Medical Devices Safety Authority (Medsafe)
• Ministry of Health – New Zealand
• Medicines Act 1981 & Medicines Regulations 1984
• Therapeutic Products Act (transition framework)
• Health Research Council (HRC) – for clinical trials
• New Zealand Customs Service

Our Core Services – New Zealand

📘 Dossier & Technical Document Translation

• New Zealand–specific CTD / non-CTD dossier formats
• Module 1–5 translations for medicine and biologic approvals
• Data Sheets (NZ SmPC-equivalent), PILs, labels & packaging text
• Medical device technical documentation
• Clinical trial documentation (protocols, IBs, ICFs)
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS & technical files
• Import, distribution & sponsor documentation

🔍 Review of Translated Dossiers

• Technical and scientific review of translated documents
• Cross-verification with source dossiers
• Identification of terminology errors, inconsistencies & compliance gaps
• Alignment with Medsafe guidance, ICH & adopted international standards

🛡️ Post-Submission Regulatory Query Handling – New Zealand

• Medsafe clarification requests & deficiency letters related to translated content
• Scientific clarification and New Zealand-style regulatory re-wording support
• Revised translations responding to authority observations
• Coordination with local sponsors, CROs & regulatory consultants

Languages We Support (New Zealand-Focused)

We provide professional, native-level regulatory translations relevant to New Zealand submissions:

🌍 International Languages

• English (primary regulatory language)
• Chinese
• Japanese
• Korean
• French
• German

Foreign Language ↔ English

All translations are reviewed by scientific and regulatory experts familiar with Medsafe requirements.

Industries We Serve – New Zealand

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Biologics & Vaccines
• Biotechnology & Advanced Therapies
• Medical Devices & IVDs
• Clinical Trials & CROs
• OTC & Consumer Health Products
• Food Supplements & Nutraceuticals
• Chemicals & Specialty Materials

Why Choose DossierTrans for New Zealand?

✅ Medsafe-focused regulatory translation (not generic translation)
✅ Expertise in NZ CTD, Data Sheets & sponsor documentation
✅ Native-level scientific & regulatory reviewers
✅ Consistent terminology aligned with Medsafe guidance
✅ Authority-ready documentation
✅ End-to-end support including post-submission queries
✅ Strict confidentiality & data security

Global & New Zealand Regulatory Expertise

Our New Zealand services support:

• Medsafe approvals & variations
• Import & distribution authorization dossiers
• Export-support translations for Australia, EU, US & ROW markets
• Post-approval changes, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence—especially in Data Sheets, labels, or regulatory correspondence—can delay or jeopardize a Medsafe approval.

That’s why we deliver precision-driven, regulator-acceptable translations, aligned with New Zealand’s regulatory and compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in New Zealand