DossierTrans – Singapore

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

We support Singapore 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 Singapore.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Singapore 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 Singapore-specific HSA / MOH expectations

Singapore Regulatory Alignment

Our services are aligned with the requirements of:

• Health Sciences Authority (HSA), Singapore
• Ministry of Health (MOH), Singapore
• Medicines Act & Health Products Act
• ASEAN Harmonized Technical Requirements (ACTD / ACTR)
• Medical Device Authority (HSA Medical Device Branch)
• Singapore Customs
• Other applicable import & export regulatory authorities in Singapore

Our Core Services – Singapore

📘 Dossier & Technical Document Translation

• Singapore-specific ACTD / CTD / non-CTD dossier formats
• Administrative & technical dossier translations for HSA submissions
• Labels, package inserts, leaflets & artwork text (English-compliant, Singapore format)
• 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 HSA guidelines, ACTD references, and MOH requirements

🛡️ Post-Submission Regulatory Query Handling – Singapore

• HSA / MOH 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 distributors

Languages We Support (Singapore-Focused)

🌍 International Languages

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

🇸🇬 Local & Regional Language Support

• English (primary regulatory language)
• Chinese (Simplified / Traditional) – where applicable
• Malay & Tamil – for specific labeling or local requirements

English ↔ Chinese | Foreign Language ↔ English / Chinese

All translations are reviewed by regulatory experts experienced with HSA and ASEAN submission requirements.

Industries We Serve – Singapore

• Pharmaceuticals & APIs
• Medical Devices
• Vaccines & Biologicals
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Traditional & Herbal Medicines
• Essential Oils & Fragrances
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Singapore?

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

Global & Singapore Regulatory Expertise

Our Singapore services support:

• HSA product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Export-support translations for ASEAN, APAC & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject an HSA approval in Singapore.

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

DossierTrans – Translating Science into Regulatory Approval in Singapore

If you want next, I can:
✔ Prepare SEO-optimized Singapore landing page content
✔ Create English–Chinese bilingual brochures
✔ Develop HSA-only pharma / medical device / food versions
✔ Convert this for Malaysia, Thailand, Vietnam, GCC, Africa, or LATAM