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 β Brunei Darussalam
π 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
π 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
π‘οΈ Post-Submission Regulatory Query Handling β 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:
π International Languages (for Import & Export)π§π³ Official and Regional Language Support* English* Malay (Bahasa Melayu) (Official Language)* Chinese (Simplified & Traditional)English β Malay | Malay β 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 β 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?
β Brunei-regulatory-focused translation (not generic translation)
β Expertise in AHPC/DCA documentation and standards
β Native-language scientific reviewers
β Terminology consistency across submissions
β Authority-ready documentation
β End-to-end support including post-approval queries
β Strict confidentiality & data security
Our Commitment
At DossierTrans, we understand that a single mistranslated sentence can delay or reject a Brunei regulatory approval. Thatβs why we deliver precision-driven, regulator-acceptable translations aligned with Brunei compliance expectationsβevery time.
DossierTrans β Translating Science into Regulatory Approval in Brunei Darussalam.
