DossierTrans

Brunei 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 Brunei Darussalam-specific dossiers and technical documents, aligned with the Authority for Health Promotion, Health Care and Standards (AHPC) and other national statutory requirements.

We support manufacturers, exporters, importers, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, registrations, and approvals in Brunei Darussalam.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Brunei 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 that translated dossiers maintain:

  • Scientific accuracy

  • Regulatory intent

  • Terminology consistency

  • Compliance with AHPC expectations

Brunei Regulatory Alignment

Our services are aligned with the requirements of:

  • Authority for Health Promotion, Health Care and Standards (AHPC) (formerly under Ministry of Health)

  • Drug Control Authority (DCA) (for pharmaceuticals)

  • Requirements related to product registration and import licensing

  • ASEAN guidelines where applicable (Brunei is an ASEAN member state)

Our Core Services – Brunei Darussalam

πŸ“˜ Dossier & Technical Document Translation

  • Brunei-specific dossier formats (often based on ASEAN CTD or local requirements)

  • Translation of modules/sections for AHPC/DCA submissions

  • SmPC, PIL, labels, leaflets & artwork text (Brunei-compliant)

  • Stability, validation & study reports

  • SOPs, specifications, COAs, SDS & technical files

  • Import registration and product licensing documentation

πŸ” Review of Translated Dossiers

  • Technical and scientific review of translated documents

  • Cross-verification with source (e.g., English) dossiers

  • Identification of terminology errors, inconsistencies & compliance gaps

  • Alignment with official Brunei guidelines and applicable regulatory references

πŸ›‘οΈ Post-Submission Regulatory Query Handling – Brunei

  • AHPC/DCA queries related to translated content

  • Scientific clarification and regulatory re-wording support

  • Revised translations as per authority observations

  • Coordination with applicants, consultants, and local agents/importers

Languages We Support (Brunei Focused)

We provide professional, native-level regulatory translations relevant to Brunei submissions and imports:

🌍 International Languages (for Import & Export)πŸ‡§πŸ‡³ Official and Regional Language Support* English* Malay (Bahasa Melayu) (Official Language)* Chinese (Simplified & Traditional)English ↔ Malay | Malay ↔ English* Arabic* Other regional languages (on request)* Other ASEAN languages (on request)

All translations are reviewed by scientific and regulatory experts familiar with Brunei and ASEAN regulations.

Industries We Serve – Brunei

We provide specialized translation and review services for:

  • Pharmaceuticals & APIs

  • Medical Devices

  • Traditional Medicines & Health Supplements

  • Cosmetics & Personal Care

  • Food Products

  • Industrial Chemicals

Why Choose DossierTrans for Brunei?

βœ… Brunei-regulatory-focused translation (not generic translation)

βœ… Expertise in AHPC/DCA documentation and standards

βœ… Native-language scientific reviewers

βœ… Terminology consistency across submissions

βœ… Authority-ready documentation

βœ… End-to-end support including post-approval queries

βœ… Strict confidentiality & data security

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a Brunei regulatory approval. That’s why we deliver precision-driven, regulator-acceptable translations aligned with Brunei compliance expectationsβ€”every time.

DossierTrans – Translating Science into Regulatory Approval in Brunei Darussalam.