DossierTrans – Malaysia

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

We support Malaysian 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 Malaysia.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Malaysian 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 Malaysia-specific NPRA / MoH expectations

Malaysia Regulatory Alignment

Our services are aligned with the requirements of:

• National Pharmaceutical Regulatory Agency (NPRA) – Ministry of Health Malaysia
• Ministry of Health (MoH), Malaysia
• Drug Control Authority (DCA)
• ASEAN Harmonized Technical Requirements (ACTD / ACTR)
• Medical Device Authority (MDA) – for medical devices
• Department of Standards Malaysia (DSM)
• Royal Malaysian Customs Department
• Department of Islamic Development Malaysia (JAKIM) – Halal (where applicable)

Our Core Services – Malaysia

📘 Dossier & Technical Document Translation

• Malaysia-specific ACTD / non-ACTD dossier formats
• Administrative & technical dossier translations for NPRA submissions
• Labels, package inserts, leaflets & artwork text (Bahasa Malaysia–compliant)
• 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 NPRA guidelines, ACTD references, and MoH requirements

🛡️ Post-Submission Regulatory Query Handling – Malaysia

• NPRA / DCA / MDA 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 (Malaysia-Focused)

🌍 International Languages

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

🇲🇾 Local & Regional Language Support

• Bahasa Malaysia (Malay)
• English (Malaysia regulatory format)

English ↔ Bahasa Malaysia | Foreign Language ↔ English / Bahasa Malaysia

All translations are reviewed by regulatory experts experienced with NPRA, DCA, and ASEAN submission requirements.

Industries We Serve – Malaysia

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

Why Choose DossierTrans for Malaysia?

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

Global & Malaysia Regulatory Expertise

Our Malaysia services support:

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

Our Commitment

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

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

DossierTrans – Translating Science into Regulatory Approval in Malaysia

If you’d like next, I can:
✔ Prepare SEO-optimized Malaysia landing page content
✔ Create Bahasa Malaysia–English bilingual brochures
✔ Develop NPRA-only pharma / cosmetics / medical device versions
✔ Convert this for Singapore, Thailand, Vietnam, GCC, Africa, or LATAM